United States         Environmental Criteria and
Environmental Protection   Assessment Office
Agency           Research Triangle Park, NC 27711
                                   EPA-600/8-83/028dF
                                   June 1986
Research and Development
Air Quality
Criteria for  Lead
Volume IV of IV

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                              EPA/600/8-83/028dF
                              June 1986
Air Quality Criteria for Lead
         Volume IV of IV
      U.S. ENVIRONMENTAL PROTECTION AGENCY
         Office of Research and Development
     Office of Health and Environmental Assessment
      Environmental Criteria and Assessment Office
         Research Triangle Park, NC 27711

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                                DISCLAIMER
     This document has been reviewed in accordance with U.S.  Environmental
Protection Agency policy and approved for publication.   Mention of trade
names or commercial products does not constitute endorsement or
recommendation.
                                    ii

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                                 ABSTRACT

     The document evaluates and  assesses scientific information on the health
and welfare effects associated with exposure to various concentrations  of lead
in ambient air.   The  literature  through 1985 has been reviewed thoroughly for
information relevant  to air  quality  criteria, although  the  document  is  not
intended as  a complete  and  detailed review  of all  literature pertaining to
lead.   An  attempt has  been  made  to  identify the  major  discrepancies in our
current knowledge and understanding of the effects of these pollutants.
     Although  this  document   is  principally  concerned with  the  health  and
welfare effects  of  lead, other scientific data are presented and evaluated in
order to provide a better understanding of this pollutant in the environment.
To  this end,  the  document includes  chapters  that discuss the chemistry and
physics  of  the  pollutant;  analytical  techniques;   sources,   and types  of
emissions;  environmental  concentrations  and  exposure  levels;  atmospheric
chemistry  and dispersion  modeling;  effects  on vegetation;  and respiratory,
physiological, toxicological, clinical, and  epidemiological  aspects  of human
exposure.
                                     iii

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                                           CONTENTS
                                                                                          Page
VOLUME I
  Chapter 1.  Executive Summary and Conclusions 	    1-1

VOLUME II
  Chapter 2.   Introduction 	    2-1
  Chapter 3.   Chemical and Physical Properties 	    3-1
  Chapter 4.   Sampling and Analytical Methods for Environmental Lead 	    4-1
  Chapter 5.   Sources and Emissions 	    5-1
  Chapter 6.   Transport and Transformation 	    6-1
  Chapter 7.   Environmental Concentrations and Potential Pathways to Human Exposure ..    7-1
  Chapter 8.   Effects of Lead on Ecosystems 	    8-1

VOLUME III
  Chapter 9.   Quantitative Evaluation of Lead and Biochemical Indices of Lead
               Exposure in Physiological Media 	    9~*
  Chapter 10.  Metabolism of Lead	   10~l
  Chapter 11.  Assessment of Lead Exposures and Absorption in Human Populations  	   11~1

Volume IV
  Chapter 12.  Biological Effects of Lead Exposure 	   1Z~1
  Chapter 13.  Evaluation of Human  Health Risk Associated with Exposure  to  Lead
               and  Its Compounds  	   13
                                                iv

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                                       TABLE OF CONTENTS
                                                                                           Page

LIST OF FIGURES 	       ix
LIST OF TABLES 	       ix

12.   BIOLOGICAL EFFECTS OF LEAD EXPOSURE 	       12-1
     12.1  INTRODUCTION	         12-1
     12.2  SUBCELLULAR EFFECTS OF LEAD IN HUMANS AND EXPERIMENTAL ANIMALS 	      12-3
           12.2.1  Effects of Lead on the Mitochondrion 	      12-4
                   12.2.1.1  Effects of Lead on Mitochondrial Structure 	      12-4
                   12.2.1.2  Effects of Lead on Mitochondrial Function 	      12-5
                   12.2.1.3  In Vivo Studies 	      12-5
                   12.2.1.4  In Vitro Studies 	      12-7
           12.2.2  Effects of Lead on the Nucleus 	      12-8
           12.2.3  Effects of Lead on Membranes 	      12-9
           12.2.4  Other Organellar Effects of Lead 	      12-10
           12.2.5  Summary of Subcellular Effects of Lead 	      12-10
     12.3  EFFECTS OF LEAD ON HEME BIOSYNTHESIS AND ERYTHROPOIESIS/ERYTHROCYTE
           PHYSIOLOGY IN HUMANS AND ANIMALS 	     12-13
           12.3.1  Effects of Lead on Heme Biosynthesis 	     12-13
                   12.3.1.1  Effects of Lead on 6-Aminolevulinic Acid Synthetase 	     12-14
                   12.3.1.2  Effects of Lead on 6-Aminolevulinic Acid Dehydrase and
                             ALA Accumulation/Excretion 	     12-15
                   12.3.1.3  Effects of Lead on Heme Formation from Protoporphyrin ...     12-20
                   12.3.1.4  Effects of Lead on Coproporhyrin 	     12-27
           12.3.2  Effects of Lead on Erythropoiesis and Erythrocyte Physiology 	     12-28
                   12.3.2.1  Effects of Lead on Hemoglobin Production 	     12-28
                   12.3.2.2  Effects of Lead on Erythrocyte Morphology and Survival ..     12-29
                   12.3.2.3  Effects of Lead on Pyrimidine-S'-Nucleotidase Activity
                             and Erythropoietic Pyrimidine Metabolism 	     12-31
           12.3.3  Effects of Alkyl Lead on Heme Synthesis and Erythopoiesis 	     12-33
           12.3.4  The Interrelationship of Lead Effects on Heme Synthesis and
                   the Nervous System	     12-34
           12.3.5  Interference with Vitamin D Metabolism and Associated
                   Physiological Processes 	     12-37
                   12.3.5.1  Relevant Clinical Studies 	     12-38
                   12.3.5.2  Experimental Studies 	     12-39
                   12.3.5.3  Implications of Lead Effects on Vitamin D Metabolism 	     12-40
           12.3.6  Summary and Overview 	     12-43
                   12.3.6.1  Lead Effects on Heme Biosynthesis 	     12-43
                   12.3.6.2  Lead Effects on Erythropoiesis and
                             Erythrocyte Physiology 	     12-48
                   12.3.6.3  Effects of Lead on Erythropoietic Pyrimidine
                             Metabol i sm	     12-48
                   12.3.6.4  Effects of Alkyl Lead Compounds on Heme Biosynthesis
                             and Erythropoiesis 	     12-49
                   12.3.6.5  Relationships of Lead Effects on
                             Heme Synthesis and Neurotoxicity 	     12-49
                   12.3.6.6  Summary of Effects of Lead on Vitamin D Metabolism 	     12-50
     12.4  NEUROTOXIC EFFECTS OF LEAD 	     12-52
           12.4.1  Introduction 	     12-52
           12.4.2  Human Studies 	     12-53
                   12.A.2.1  Neurotoxic Effects of Lead Exposure in Adults 	     12-56
                   12.4.2.2  Neurotoxic Effects of Lead Exposure in Children 	     12-68

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                           TABLE OF CONTENTS  (continued).
      12.4.3  Animal  Studies  	    12-110
              12.4.3.1   Behavioral  Toxicity:   Critical  Periods  for Exposure and
                        Expression  of  Effects  	    12-112
              12.4.3.2   Morphological  Effects  	    12-139
              12.4.3.3   Electrophysiological Effects  	    12-142
              12.4.3.4   Biochemical  Alterations  	    12-145
              12.4.3.5   Accumulation and Retention of Lead in the Brain 	    12-150
      12.4.4  Integrative  Summary of Human and Animal Studies of Neurotoxicity ..    12-155
              12.4.4.1   Internal  Exposure Levels at Which Adverse
                        Neurobehavioral  Effects  Occur 	    12-155
              12.4.4.2   The Question of  Irreversibility 	    12-158
              12.4.4.3   Early Development and  the Susceptibility to
                        Neural  Damage  	    12-158
              12.4.4.4   Utility of  Animal Studies in  Drawing Parallels
                        to the Human Condition 	    12-159
12.5  EFFECTS OF LEAD ON THE KIDNEY 	    12-164
      12.5.1  Historical Aspects 	    12-164
      12.5.2  Lead Nephropathy in Childhood 	    12-164
      12.5.3  Lead Nephropathy in Adults 	    12-165
              12.5.3.1  Lead Nephropathy Following Childhood Lead Poisoning 	    12-166
              12.5.3.2  "Moonshine" Lead Nephropathy	    12-167
              12.5.3.3  Occupational Lead Nephropathy	    12-167
              12.5.3.4  Lead and Gouty Nephropathy 	    12-172
              12.5.3.5  Lead and Hypertensive Nephrosclerosis 	    12-175
              12.5.3.6  General Population Studies 	    12-177
      12.5.4  Mortality Data 	    12-178
      12.5.5  Experimental Animal Studies of the Pathophysiology of
              Lead Nephropathy  	    12-179
              12.5.5.1  Lead Uptake By the Kidney  	   12-179
              12.5.5.2  Intracellular Binding of  Lead in the Kidney 	    12-180
              12.5.5.3  Pathological  Features of  Lead Nephropathy  	   12-181
              12.5.5.4  Functional  Studies 	   12-181
      12.5.6  Experimental Studies  of the Biochemical Aspects of
              Lead Nephrotoxicity  	   12-183
              12.5.6.1  Membrane Marker  Enzymes and  Transport Functions  	   12-183
              12.5.6.2  Mitochondrial Respiration/Energy-Linked
                        Transformation  	   12-184
              12.5.6.3  Renal  Heme  Biosynthesis  	   12-185
              12.5.6.4  Alteration  of Renal Nucleic  Acid/Protein  Synthesis 	   12-187
              12.5.6.5   Lead Effects  on the Renin-Angiotension  System 	   12-188
              12.5.6.6   Effects of Lead on Uric  Acid Metabolism 	   12-189
              12.5.6.7   Effects of Lead on Kidney Vitamin D Metabolism 	   12-189
       12.5.7 General Summary:   Comparison of Lead's Effects on Kidneys  in
              Humans and  Animal  Models  	   12-190
 12.6  EFFECTS OF LEAD ON  REPRODUCTION AND DEVELOPMENT 	   12-192
       12.6.1 Human  Studies  	   12-192
              12.6.1.1   Historical  Evidence  	   12-192
              12.6.1.2   Effects of Lead Exposure on  Reproduction 	   12-193
              12.6.1.3   Placental  Transfer of Lead 	   12~a7
               12.6.1.4   Effects of Lead on the  Developing Human 	    12no
              12.6.1.5   Summary of the  Human  Data 	    12-202

                                          vi

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                           TABLE OF CONTENTS (continued).
      12.6.2  Animal Studies 	   12-202
              12.6.2.1  Effects of Lead on Reproduction 	   12-202
              12.6.2.2  Effects of Lead on the Offspring 	   12-206
              12.6.2.3  Effects of Lead on Avian Species 	   12-219
      12.6.3  Summary 	         12-219
12.7  GENETOXIC AND CARCINOGENIC EFFECTS OF LEAD 	'.'.'.'.'.'.   12-221
      12.7.1  Introduction 	   12-221
      12.7.2  Carcinogenesis Studies with Lead and its Compounds 	   12-224
              12.7.2.1  Human Epidemic!ogical Studies 	   12-224
              12.7.2.2  Induction of Tumors in Experimental Animals 	   12-229
              12.7.2.3  Cell Transformation 	   12-234
      12.7.3  Genotoxicity of Lead 	   12-236
              12.7.3.1  Chromosomal Aberrations 	   12-236
              12.7.3.2  Sister Chromatid Exchange 	   12-240
              12.7.3.3  Effect of Lead on Bacterial and Mammalian
                        Mutagenesis Systems 	   12-242
              12.7.3.4  Effect of Lead on Parameters of DNA
                        Structure and Functi on 	   12-242
      12.7.4  Lead as an Initiator and Promoter of Carcinogenesis 	   12-244
      12.7.5  Summary and Conclusions 	   12-244
12.8  EFFECTS OF LEAD ON THE IMMUNE SYSTEM	   12-246
      12.8.1  Development and Organization of the Immune System 	   12-246
      12.8.2  Host Resistance 	   12-247
              12.8.2.1  Infectivity Models 	   12-248
              12.8.2.2  Tumor Models and Neoplasia 	   12-250
      12.8.3  Humoral Immunity 	   12-251
              12.8.3.1  Antibody Titers 	   12-251
              12.8.3.2  Enumeration of Antibody Producing Cells
                        (Plaque-Forming Cells) 	   12-252
      12.8.4  Cell-Mediated Immunity 	   12-254
              12.8.4.1  Delayed-Type Hypersensitivity 	   12-254
              12.8.4.3  Interferon 	   12-256
      12.8.5  Lymphocyte Activation by Mitogens 	   12-256
              12.8.5.1  In Vivo Exposure 	   12-256
              12.8.5.2  Tn Vvtro Exposure 	   12-258
      12.8.6  MacrophageTunction 	   12-259
      12.8.7  Mechanisms of Lead Immunomodulation 	   12-261
      12.8.8  Summary 	   12-261
12.9  EFFECTS OF LEAD ON OTHER ORGAN SYSTEMS 	   12-262
      12.9.1  The Cardiovascular System 	   12-262
      12.9.2  The Hepatic System 	   12-264
      12.9.3  The Gastrointestinal System 	   12-266
      12.9.4  The Endocrine System 	   12-268
12.10 CHAPTER SUMMARY 	   12-271
      12.10.1 Introduction 	   12-271
      12.10.2 Subcel1ular Effects of Lead 	   12-271
      12.10.3 Effects of Lead on Heme Biosynthesis, Erythropoiesis, and
              Erythrocyte Physiology in Humans and Animals 	   12-274
      12.10.4 Neurotoxic Effects of Lead 	   12-281
              12.10,4.1  Internal Exposure Levels at Which Adverse
                         Neurobehavioral Effects Occur 	   12-281

                                         vi i

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                                TABLE OF CONTENTS (continued).
                   12.10.4.2  The Question of Irreversibility 	    12-283
                   12.10.4.3  Early Development and the Susceptibility to Neural
                              Damage 	    12-283
                   12.10.4.4  Utility of Animal Studies in Drawing Parallels to the
                              Human Condition 	    12-284
           12.10.5 Effects of Lead on the Kidney 	    12-286
           12.10.6 Effects of Lead on Reproduction and Development 	    12-287
           12.10.7 Genotoxic and Carcinogenic Effects of Lead 	    12-289
           12.10.8 Effects of Lead on the Immune System 	    12-289
           12.10.9 Effects of Lead on Other Organ Systems 	    12-289
     12.11 REFERENCES 	    12-291
           APPENDIX 12-A	     12A-1


13.1  INTRODUCTION 	     13-1
13.2  EXPOSURE ASPECTS 	     13-2
      13.2.1  Sources of Lead Emission in the United States 	     13-2
      13.2.2  Environmental  Cycling of Lead 	     13-4
      13.2.3  Levels of Lead in Various Media of Relevance to Human Exposure 	     13-5
              13.2.3.1  Ambient Air Lead Levels 	     13-6
              13.2.3.2  Levels of Lead in Dust	     13-6
              13.2.3.3  Levels of Lead in Food 	     13-7
              13.2.3.4  Lead Levels in Drinking Water 	     13-7
              13.2.3.5  Lead in Other Media 	     13-11
              13.2.3.6  Cumulative Human Lead Intake From Various Sources 	     13-11
13.3  LEAD METABOLISM:   KEY ISSUES FOR HUMAN HEALTH RISK EVALUATION 	     13-11
      13.3.1  Differential Internal Lead Exposure Within Population Groups 	     13-12
      13.3.2  Indices of Internal Lead Exposure and Their Relationship to External
               Lead Levels and Tissue Burdens/Effects 	     13-13
13.4  DEMOGRAPHIC CORRELATES OF HUMAN LEAD EXPOSURE AND RELATIONSHIPS BETWEEN
      EXTERNAL AND INTERNAL LEAD EXPOSURE INDICES 	     13-17
      13.4.1  Demographic Correlates of Lead Exposure 	     13-17
      13.4.2  Relationships Between External and Internal Lead Exposure Indices 	     13-19
      13.4.3  Proportional Contributions of Lead in Various Media to Blood Lead in
                Human Populations 	     13-26
13.5  BIOLOGICAL EFFECTS OF LEAD RELEVANT TO THE GENERAL HUMAN POPULATION 	     13-27
      13.5.1  Introduction 	     13-27
      13.5.2  Dose-Effect Relationship for Lead-Induced Health Effects 	     13-32
              13.5.2.1  Human Adults 	     13-32
              13.5.2.2  Children 	     13-34
13.6  DOSE-RESPONSE RELATIONSHIPS FOR LEAD IN HUMAN POPULATIONS 	     13-41
13.7  POPULATIONS AT RISK 	     13-44
      13.7.1  Children as a Population at Risk	     13-44
              13.7.1.1  Inherent Susceptibility of the Young	     13-45
              13.7.1.2  Exposure Consideration 	     13-45
      13.7.2  Pregnant Women and the Conceptus as a Population at Risk	     13-46
      13.7.3  Middle-Aged White Males (Aged 40-59) as a Population at Risk 	     13-47
      13.7.4  Description of the United States Population in Relation to Potential
                Lead Exposure Risk	     13-47
13.8  SUMMARY AND CONCLUSIONS	     13-49
13.9  REFERENCES 	     13-51

                                             viii

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                                        LIST OF  FIGURES

Figure                                                                                   Page

 12-1  Effects on lead (Pb)  on heme biosynthesis 	    12-14
 12-2  Regression of IQ scores against blood lead levels,  with  95% confidence
       band.   Double values  indicated by triangle 	    12-93
 12-3  (a) Predicted SW voltage and 95% confidence bounds  in 13-  and 75-month-old
       children as a function of blood lead level,   (b)  Scatter plots of SW data
       from children aged 13-47 months with predicted regression  lines for ages
       18, 30, and 42 months,   (c) Scatter plots for children aged 48-75 months
       with predicted regression lines for ages  54 and 66  months.   These graphs
       depict the linear interaction of blood lead level  and age  	    12-105
 12-4  Peroneal nerve conduction velocity versus blood lead level, for children
       living in a smelter area of Idaho, 1974 	    12-109


 13-1  Pathways of lead from the environment to  man, main compartments involved
       in partitioning of internal body burden of absorbed/retained lead, and
       main routes of lead excretion 	    13-3
 13-2  Body compartments involved in partitioning, retention, and excretion of
       absorbed lead and selected target organs  for lead toxicity 	    13-15
 13-3  Geometric mean blood lead levels by race  and age for younger children in  the
       NHANES II study, the Kellogg/Silver Valley, and New York childhood screening
       studies 	    13-18
 13-4  Multi-organ impact of reduction of heme body pool  by lead 	    13-31
 13-5  Dose-response for elevation of EP as a function of blood lead level using
       probit analysis 	    13-42
 13-6  Dose-response curve for FEP as a function of blood lead level:
       in subpopulations	    13-43
 13-7  EPA calculated dose-response curve for ALA-U 	    13-43
                                        LIST OF TABLES

Table

 12-1  Summary of studies on nerve conduction velocity in groups of lead-exposed
       subjects 	
 12-2  Summary of studies on neurobehavioral functions of lead-exposed children ..
 12-3  Effects of lead on activity in rats and mice 	
 12-4  Recent animal toxicology studies of lead's effects on learning in rodents .
 12-5  Recent animal toxicology studies of lead's effects on learning in primates
 12-6  Summary of key studies of morphological effects of vn vivo lead exposure ..
 12-7  Summary of key studies of electrophysiological effects of HI vivo lead
       exposure 	
 12-8  Summary of key studies on biochemical effects of ijn vivo lead exposure 	
 12-9  Index of blood lead and brain lead levels following exposure 	
 12-10 Summary of key studies of iji vitro lead exposure 	
 12-11 Morphological features of lead nephropathy in various species 	
 12-12 Effects of lead exposure on aspects of renal heme biosynthesis 	
 12-13 Statistics on the effect of lead on pregnancy 	
 12-14 Effects of prenatal exposure to lead on the offspring of laboratory and
       domestic animals: studies using oral or inhalation routes of exposure 	
Page
12-62
12-73
12-116
12-118
12-128
12-140

12-143
12-146
12-151
12-162
12-182
12-186
12-193

12-207

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                                 LIST OF TABLES  (continued).

Table                                                                                      Page

 12-15 Effects of prenatal lead exposure on offspring of laboratory animals:
       results of studies employing administration of lead by injection 	     12-209
 12-16 Reproductive performance of Fx lead-intoxicated rats (means ± standard
       errors) 	     12-212
 12-17 Expected and observed deaths and standardized mortality ratios for
       malignant neoplasms Jan.  1, 1947 - Dec.  31, 1979 for lead smelter and
       battery pi ant workers 	     12-225
 12-18 Expected and observed deaths resulting from specified malignant neoplasms
       for lead smelter and battery plant workers and levels of significance  by
       type of statistical analysis according to one-tailed tests 	     12-226
 12-19 Examples of studies on the incidence of tumors in experimental animals
       exposed to lead compounds 	     12-230
 12-20 Mortality and kidney tumors in rats fed lead acetate for two years 	     12-234
 12-21 Cytogenetic investigations of cells from individuals exposed to lead:
       positive studies 	     12-237
 12-22 Cytogenetic investigations of cells from individuals exposed to lead:
       negative studies 	     12-238
 12-23 Effect of lead on host resistance to infectious agents 	     12-248
 12-24 Effect of lead on antibody titers 	     12-251
 12-25 Effect of lead on the development of antibody-producing cells 	     12-253
 12-26 Effect of lead on cell-mediated immunity 	     12-255
 12-27 Effect of lead exposure on mitogen activation of lymphocytes 	     12-257
 12-28 Effect of lead on macrophage and reticyloendothelial system function 	     12-260
 12-A  Tests commonly used in a psycho-educational battery for children 	     12-A2


 13-1  Summary of baseline human exposures to lead 	     13-8
 13-2  Relative baseline human lead exposures expressed per kilogram body weight 	     13-9
 13-3  Summary of potential additive exposures to lead (ug/day) 	     13-10
 13-4  Summary of blood inhalation slopes, O) 	     13-20
 13-5  Estimated contribution of leaded gasoline to blood lead by inhalation  and
       non-inhalation pathways 	     13-25
 13-6  Contributions from various media to blood lead (ng/dl) of U.S. children
       (Age = 2 years): Background levels and incremental contributions from  air 	     13-28
 13-7  Summary of lowest observed effect levels for key lead-induced health effects
       in adults 	     13-33
 13-8  Summary of lowest observed effect levels for key lead-induced health effects
       in children 	     13-35
 13-9  EPA-estimated percentage of subjects with ALA-U exceeding limits for various
       blood lead levels 	     13-44
 13-10 Provisional estimate of the number of individuals in urban and rural
       population segments at greatest potential risk to lead exposure 	     13-48

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                                     LIST OF ABBREVIATIONS
AAS
Ach
ACTH
ADCC
ADP/0 ratio
AIDS
AIHA
All
ALA
ALA-D
ALA-S
ALA-U
APDC
APHA
ASTM
ASV
ATP
B-cells
Ba
BAL
BAP
BSA
BUN
BW
C.V.
CaBP
CaEDTA
CaNa2EDTA
CBD
Cd
CDC
CEC
CEH
CFR
CMP
CNS
CO
COHb
CP-U

cBah
D.F.
DA
6-ALA
DCMU
DPP
DMA
DTH
EEC
EEG
EMC
EP
Atomic absorption spectrometry
Acetylcholine
Adrenocorticotrophic hormone
Antibody-dependent cell-mediated cytotoxicity
Adenosine diphosphate/oxygen ratio
Acquired immune deficiency syndrome
American Industrial Hygiene Association
Angiotensin II
Aminolevulinic acid
Aminolevulinic acid dehydrase
Aminolevulinic acid synthetase
Aminolevulinic acid in urine
Ammonium pyrrolidine-dithiocarbamate
American Public Health Association
Amercian Society for Testing and Materials
Anodic stripping voltammetry
Adenosine triphpsphate
Bone marrow-derived lymphocytes
Barium
British anti-Lewisite (dimercaprol)
benzo(a)pyrene
Bovine serum albumin
Blood serum urea nitrogen
Body weight
Coefficient of variation
Calcium binding protein
Calci urn ethylenedi ami netetraacetate
Calcium disodium ethylenediaminetetraacetate
Central business district
Cadmium
Centers for Disease Control
Cation exchange capacity
Center for Environmental Health
reference method
Cytidine monophosphate
Central nervous system
Carbon monoxide
Carboxyhemoglobi n
Urinary coproporphyrin
plasma clearance of p-aminohippuric acid
Copper
Degrees of freedom
Dopamine
delta-aminolevulinic acid
[3-(3,4-dichlorophenyl)-l,l-dimethyl urea
Differential pulse polarography
Deoxyribonucleic acid
Delayed-type hypersensitivity
European Economic  Community
Electroencephalogram
Encephalomyocardi ti s
Erythrocyte protoporphyrin

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                               LIST OF ABBREVIATIONS  (continued).


EPA                      U.S.  Environmental Protection Agency
FA                       Fulvic acid
FDA                      Food  and Drug Administration
Fe                       Iron
FEP                      Free  erythrocyte protoporphyrin
FY                       Fiscal year
G.M.                     Grand mean
G-6-PD                   Glucose-6-phosphate dehydrogenase
GABA                     Gamma-aminobutyric acid
GALT                     Gut-associated lymphoid tissue
GC                       Gas chromatography
GFR                      Glomerular filtration rate
HA                       Humic acid
Hg                       Mercury
hi-vol                   High-volume air sampler
HPLC                     High-performance liquid chromatography
i-ii.                     Intramuscular (method of injection)
i-P-                     Intraperitoneally (method of injection)
i-V.                     Intravenously (method of injection)
IAA                      Indol-3-ylacetic acid
IARC                     International Agency for Research on Cancer
ICD                      International classification of diseases
ICP                      Inductively coupled plasma emission spectroscopy
IDMS                     Isotope dilution mass spectrometry
IF                       Interferon
HE                      Isotopic Lead Experiment (Italy)
IRPC                     International Radiological Protection Commission
K                        Potassium
LDH-X                    Lactate dehydrogenase isoenzyme x
LCj-Q                     Lethyl concentration (50 percent)
LDgQ                     Lethal dose (50 percent)
LH                       Luteinizing hormone
LIPO                     Laboratory Improvement Program Office
In                       Natural logarithm
LPS                      Lipopolysaccharide
LRT                      Long range transport
mRNA                     Messenger ribonucleic acid
ME                       Mercaptoethanol
MEPP                     Miniature end-plate potential
MES                      Maximal electroshock seizure*
MeV                      Mega-electron volts
MLC                      Mixed lymphocyte culture
HMD                      Mass median diameter
MMAD                     Mass median aerodynamic diameter
Mn                       Manganese
MND                      Motor neuron disease
MSV                      Moloney sarcoma virus
MTD                      Maximum tolerated dose
n                        Number of subjects or observations
N/A                      Not Available
                                              XI1

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                                     LIST OF ABBREVIATIONS
NA
NAAQS
NAD
NADB
NANS
NAS
NASN
NBS
NE
NFAN
NFR-82
NHANES II
Ni
NTA
OSHA
P
P
PAH
Pb
PBA
Pb(Ac),
PbB   *
PbBrCl
PBG
PFC
pH
PHA
PHZ
PIXE
PMN
PNO
PNS
p.o.
ppm
PRA
PRS
PWM
Py-5-N
RBC
RBF
RCR
redox
RES
RLV
RNA
S-HT
SA-7
s.c.
scm
S.D.
SOS
S.E.M.
Not Applicable
National ambient air quality standards
Nicotinamide Adenine Dinucleotide
National Aerometric Data Bank
National Air Monitoring Station
National Academy of Sciences
National Air Surveillance Network
National Bureau of Standards
Norepinephrine
National Filter Analysis Network
Nutrition Foundation Report of 1982
National Health Assessment and Nutritional Evaluation Survey II
Nickel
Nitrilotriacetonitrile
Occupational Safety and Health Administration
Phosphorus
Significance symbol
Para-aminohippuric acid
Lead
Air lead
Lead acetate
concentration of lead in blood
Lead (II) bromochloride
Porphobilinogen
Plaque-forming cells
Measure of acidity
Phytohemaggluti ni n
Polyacrylamide-hydrous-zirconia
Proton-induced X-ray emissions
Polymorphonuclear leukocytes
Post-natal day
Peripheral nervous system
Per os  (orally)
Parts per million
Plasma  renin activity
Plasma  renin substrate
Pokeweed mitogen
Pyri mi de-5'-nucleoti dase
Red blood cell; erythrocyte
Renal blood flow
Respiratory control ratios/rates
Oxidation-reduction potential
Reticuloendothelial system
Rauscher leukemia virus
Ribonucleic acid
Serotonin
Simian  adenovirus
Subcutaneously  (method  of  injection)
Standard cubic  meter
Standard deviation
Sodium  dodecyl  sulfate
Standard error  of  the mean
                                              xiii

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                              LIST OF ABBREVIATIONS (continued).
SES
SCOT
slg
SLAMS
SMR
Sr
SRBC
SRMs
STEL
SW voltage
T-cells
t-tests
TBL
TEA
TEL
TIBC
TML
TMLC
TSH
TSP -
U.K.
UMP
USPHS
VA
WHO
XRF
X^
Zn
ZPP
Socioeconomic status
Serum glutamic oxaloacetic transaminase
Surface immunoglobulin
State and local air monitoring stations
Standardized mortality ratio
Strontium
Sheep red blood cells
Standard reference materials
Short-term exposure limit
Slow-wave voltage
Thymus-derived lymphocytes
Tests of significance
Tri-n-butyl  lead
Tetraethyl-ammoni urn
Tetraethyllead
Total iron binding capacity
Tetramethyllead
Tetramethyllead chloride
Thyroid-stimulating hormone
Total suspended particulate
United Kingdom
Uridine monophosphate
U.S.  Public  Health Service
Veterans Administration
Deposition velocity
Visual evoked response
World Health Organization
X-Ray fluorescence
Chi squared
Zinc
Erythrocyte  zinc protoporphyrin
                                   MEASUREMENT ABBREVIATIONS
dl
ft
9,
g/gal
g/ha-mo
km/hr
1/min
mg/km
ug/m3
mm
urn
(jmol
ng/cm2
nm
nM
sec
t
deciliter
feet
gram
gram/gallon
gram/hectare-month
kilometer/hour
1i ter/mi nute
milli gram/ki1ometer
microgram/cubic meter
millimeter
micrometer
micromole
nanograms/square centimeter
nanometer
nanomole
second
tons
                    xiv

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                             GLOSSARY VOLUME IV
ADP/0 ratio - a measure of the rate of respiration;  the ratio of adenosine
              diphosphate concentration to oxygen levels increases as
              respiration is impaired
active transport - the translocation of a solute across a membrane by means of
                   an energy-dependent carrier system capable of moving against
                   a concentration gradient
affective function - pertaining to emotion
asthenospermia - loss or reduction of the motility of spermatozoa
azotemia - an excess of urea and other nitrogenous compounds in the blood
basal ganglia - all of the large masses of gray matter at the base of the
                cerebral hemispheres, including the corpus striatum, subthalamic
                nucleus, and substantia nigra
basophilic stippling - a histochemical appearance characteristic of immature
                       erythrocytes
cognitive function - pertaining to reasoning, judging, conceiving, etc.
corpuscular volume - red blood cell volume
cristae - shelf-like infoldings of the inner membrane of mitochondria
cytomegaly - markedly enlarged cells
demyelination - destruction of the protective myelin sheath which surrounds
                most nerves
depolarization  - the electrophysiological process underlying neural transmission
desaturation kinetic study - a form of kinetic study in which the rate of release
                             of a  species from its binding is studied
desquamation -  shedding, peeling,  or  scaling off
disinhibition - removal of a tonic inhibitory effect
endoneurium  - the  delicate connective tissue enveloping  individual  nerve  fibers
              within a  nerve
erythrocyte  - red  blood cell
erythropoiesis  - the formation of  red blood cells
feedback  derepression - the deactivation  of a represser
hepatocyte - a  parenchyma!  liver cell
                                       xv

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hyalinization - a histochemical  marker characteristic of degeneration
hyperkalemia - a greater than normal  concentration of potassium ions in the
               circulating blood
hyperplasia - increased numbers  of cells
hypertrophy - increased size of  cells
hypochromic - containing less than the normal  amount of pigment
hyporeninemic hypoaldosteronism  - pertaining to a systemic deficiency of renin
                                  and aldosterone
inclusion bodies - any foreign substance contained or entrapped within a cell
isocortex - cerebral cortex
lysosomes - a cytoplasmic, membrane-bound particle containing hydrolyzing
            enzymes
macrophage - large scavenger cell that ingests bacteria, foreign bodies, etc.
(Na+, K+)-ATPase - an energy-dependent enzyme which transports sodium and
                   potassium across cell membranes
natriuresis - enhanced urinary excretion of sodium
normocytic - refers to normal, heal thy-looking erythrocytes
organotypic - disease or cell mixture representative of a specific organ
oxidative phosphorylation - the  generation of cellular energy in the presence
                            of oxygen
paresis - partial or incomplete  paralysis
pathognomic feature - characteristic or indicative of a disease
polymorphonuclear leukocytes - leukocytes (white blood cells) having nuclei of
                               various forms
respiratory control rates (RCRs) - measure of intermediary metabolism
reticulocytosis - an increase in the number of circulating immature red blood
                  cells
synaptogenesis - the formation of neural connections (synapses)
synaptosomes - morphological unit composed of nerve terminals and the attached
               synapse
teratogenic - affecting the development of an organism
teratospermia - a condition characterized by the presence of malformed
                spermatozoa
                                      xv i

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Chapter 12:   Biological Effects of Lead Exposure

Contributing Authors

Dr.  Max Costa
Department of Pharmacology
University of Texas Medical School
Houston, TX  77025

Dr.  J.  Michael Davis
Environmental Criteria and Assessment Office
MD-52
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711
Dr. Jack Dean
Immunobiology Program and Immunotoxicology/
  Cell Biology Program
CUT
P.O. Box 12137
Research Triangle Park, NC  27709

Dr. Bruce Fowler
Laboratory of Pharmacology
NIEHS
P.O. Box 12233
Research Triangle Park, NC  27709

Dr. Lester Grant
Director, Environmental Criteria and
  Assessment Office
MD-52
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711

Dr. Ronald D. Hood
Department of Biology
The University of Alabama
P.O. Box 1927
University, AL  35486

Dr. Loren Keller
School of Veterinary Medicine
University of Idaho
Moscow, ID  83843

Dr. David Lawrence
Microbiology and Immunology Department
Albany Medical College of Union University
Albany, NY  12208
Dr.  Paul Mushak
Department of Pathology
UNC School of Medicine
Chapel Hill, NC  27514

Dr.  David Otto
Clinical Studies Division
MD-58
U.S.  Environmental Protection
  Agency
Research Triangle Park, NC  27711

Dr.  Magnus Piscator
Department of Environmental Hygiene
The Karolinska Institute 104 01
Stockholm
Sweden
Dr. John F. Rosen
Department of Pediatrics
Montefiore Hospital and
  Medical Center
New York, NY  10467

Dr. Stephen R. Schroeder
Division for Disorders of
  Development and Learning
Biological Sciences Research Center
University of North Carolina
Chapel Hill, NC  27514

Dr. Richard P. Wedeen
V.A. Medical Center
Tremont Avenue
East Orange, NJ  07019
Dr. David Weil
Environmental Criteria and
  Assessment Office
MD-52
U.S. Environmental Protection
  Agency
Research Triangle Park, NC  27711
                                     xvii

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The following persons reviewed this chapter at EPA's request.   The evaluations
and conclusions contained herein, however, are not necessarily those of the
reviewers.
Dr. Carol Angle
Department of Pediatrics
University of Nebraska
College of Medicine
Omaha, NE  68105

Dr. Lee Annest
Division of Health Examin.  Statistics
National Center for Health Statistics
3700 East-West Highway
Hyattsville, MD  20782

Dr. Donald Barltrop
Department of Child Health
Westminister Children's Hospital
London SW1P 2NS
England

Dr. Irv Billick
Gas Research Institute
8600 West Bryn Mawr Avenue
Chicago, IL  60631
Dr. Joe Boone
Clinical Chemistry and
  Toxicology Section
Center for Disease Control
Atlanta, GA  30333
Dr. Robert Bornschein
University of Cincinnati
Kettering Laboratory
Cincinnati, OH  45267
Dr. A. C. Chamberlain
Environmental and Medical Sciences Division
Atomic Energy Research Establishment
Harwell 0X11
England

Dr. Neil Chernoff
Division of Developmental Biology
MD-67
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711
Dr.  Julian Chisolm
Baltimore City Hospital
4940 Eastern Avenue
Baltimore, MD  21224
Dr.  Jerry Cole
International Lead-Zinc Research
  Organization
292 Madison Avenue
New York, NY  10017

Dr.  Anita Curran
Commissioner of Health
Westchester County
White Plains, NY  10607
Dr. Cliff Davidson
Department of Civil Engineering
Carnegie-Mellon University
Schenley Park
Pittsburgh, PA  15213

Dr. H. T. Delves
Chemical Pathology and Human
  Metabolism
Southampton General Hospital
Southampton S09 4XY
England

Dr. Fred deSerres
Associate Director for Genetics
NIEHS
P.O. Box 12233
Research Triangle Park, NC  27709

Dr. Joseph A. DiPaolo
Laboratory of Biology, Division
  of Cancer Cause and Prevention
National Cancer Institute
Bethesda, MD  20205

Dr. Robert Dixon
Laboratory of Reproductive  and
  Developmental Toxicology
NIEHS
P.O. Box 12233
Research Triangle Park, NC  27711
                                     xvm

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Dr. Clair Ernhart
Department of Psychiatry
Cleveland Metropolitan General Hospital
3395 Scranton Road
Cleveland, OH  44109

Dr. Sergio Fachetti
Section Head - Isotope Analysis
Chemistry Division
Joint Research Center
121020 Ispra
Varese, Italy

Dr. Virgil Perm
Department of Anatomy and Cytology
Dartmouth Medical School
Hanover, NH  03755
Dr. Alf Fischbein
Environmental Sciences Laboratory
Mt. Sinai School of Medicine
New York, NY  10029

Dr. Jack Fowle
Reproductive Effects Assessment Group
U.S. Environmental Protection Agency
RD-689
Washington, DC  20460

Dr. Bruce Fowler
Laboratory of Pharmocology
NIEHS
P.O. Box 12233
Research Triangle Park, NC  27709

Dr. Warren Galke
Department of Biostatisties and Epidemiology
School of Allied Health
East Carolina University
Greenville, NC  27834
Mr.  Eric Goldstein
Natural Resources Defense  Council,  Inc.
122  E. 42nd  Street
New  York,  NY  10168
Dr.  Harvey Gonick
1033 Gayley  Avenue
Suite  116
Los  Angeles,  CA 90024
Dr.  Robert Goyer
Deputy Director
NIEHS
P.O.  Box 12233
Research Triangle Park, NC  27711

Dr.  Philippe Grandjean
Department of Environmental Medicine
Institute of Community Health
Odense University
Denmark
Dr. Stanley Gross
Hazard Evaluation Division
Toxicology Branch
U.S. Environmental Protection
  Agency
Washington, DC  20460

Dr. Paul Hammond
University of Cincinnati
Kettering Laboratory
Cincinnati, OH  45267

Dr. Kari Hemminki
Institute of Occupational Health
Tyoterveyslaitos-Haartmaninkatu
1 SF-00290 Helsinki 29
Finland

Dr. V. Houk
Center for Disease Control
1600 Clifton Road, NE
Atlanta, GA  30333
Dr. Carole A. Kimmel
Perinatal and Postnatal  Evaluation
  Branch
National Center  for Toxicological
  Research
Jefferson, AR  72079

Dr. Kristal  Kostial
Institute for Medical  Research
  and  Occupational Health
YU-4100 Zagreb
Yugoslavia

Dr. Lawrence Kupper
Department of Biostatisties
UNC School of Public  Health
Chapel Hill, NC   27514
                                       xix

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Dr. Philip Landrigan
Division of Surveillance,
  Hazard Evaluation and Field Studies
Taft Laboratories - NIOSH
Cincinnati, OH  45226
Dr. Alais-Yves Leonard
Centre D1Etude De L'Energie Nucleaire
B-2400 Mol
Belgium

Dr. Jane Lin-Fu
Office of Maternal and Child Health
Department of Health and Human Services
Rockville, MD  20857
Dr. Don  Lynam
Air Conservation
Ethyl Corporation
451 Florida Boulevard
Baton Rouge, LA  70801

Dr. Kathryn Mahaffey
Division of Nutrition
Food and Drug Administration
1090 Tusculum Avenue
Cincinnati, OH  45226

Dr. Ed McCabe
Department of Pediatrics
University of Wisconsin
Madison, WI  53706

Dr. Chuck Nauman
Exposure Assessment Group
U.S. Environmental Protection Agnecy
Washington, DC  20460
 Dr.  Herbert  L. Needleman
 Children's Hospital of  Pittsburgh
 Pittsburgh,  PA   15213
Dr. Forrest H. Nielsen
Grand Forks Human Nutrition Research Center
USDA
Grand Forks, ND  58202
Dr.  Stephen Overman
Toxicology Institute
New York State Department of
  Health
Empire State Plaza
Albany, NY  12001

Dr.  H. Mitchell Perry
V.A. Medical Center
St.  Louis, MO  63131
Dr. Jack Pierrard
E.I. duPont de Nemours and
  Company, Inc.
Petroleum Laboratory
Wilmington, DE  19898

Dr. Sergio Piomelli
Columbia University Medical School
Division of Pediatric Hematology
  and Oncology
New York, NY  10032

Dr. Robert Putnam
International Lead-Zinc
  Research Organization
292 Madison Avenue
New York, NY  10017

Dr. Michael Rabinowitz
Children's Hospital Medical Center
300 Longwood Avenue
Boston, MA  02115

Dr. Larry Reiter
Neurotoxicology Division
MD-74B
U.S. Environmental Protection
  Agency
Research Triangle Park, NC  27711

Dr. Cecil R. Reynolds
Department of Educational  Psychology
Texas A & M University
College Station, TX  77843

Dr. Patricia Rodier
Department of Anatomy
University of Rochester Medical
  Center
Rochester, NY  14642
                                      xx

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Dr. Harry Roels
Unite de Toxicologie Industrie!le et Medicale
Um'versite de Louvain
Brussels, Belgium
Dr. John Rosen
Head, Division of Pediatric Metabolism
Montefiore Hospital and Medical Center
111 East 210 Street
Bronx, NY  10467

Dr. Michael Rutter
Department of Psychology
Institute of Psychiatry
DeCrespigny Park
London SE5 SAL
England

Dr. Anna-Maria Seppalainen
Institutes of Occupational Health
Tyoterveyslaitos
Haartmanikatu 1
00290 Helsinki 29
Finland

Dr. Ellen Silbergeld
Environmental Defense Fund
1525 18th Street, NW
Washington, DC  20036

Ms. Marjorie Smith
Department of Psychological Medicine
Hospital for Sick Children
Great Ormond Street
London WC1N 3EM
England

Mr. Peter Harvey
Environment, Health and
   Behavior Research Group
59 Selly Wick Road
The University of Birmingham
Birmingham  B29 7JF
England
Dr. Ron Snee
E.I.  duPont de Nemours and
  Company, Inc.
Engineering Department L3167
Wilmington, DE  19898

Dr. F. William Sunderman, Jr.
Department of Pharmacology
University of Connecticut
  School of Medicine
Farmington, CT  06032

Dr. Gary Ter Haar
Toxicology and Industrial
  Hygiene
Ethyl Corporation
451 Florida Boulevard
Baton Rouge, LA  70801

Dr. Hugh A. Tilson
Laboratory of Behavioral and
  Neurological Toxicology
NIEHS
Research Triangle Park, NC  27709
Mr.  Ian von Lindern
Department of Chemical Engineering
University of Idaho
Moscow, ID  83843

Dr.  William Yule
Institute of Psychiatry
DeCrespigny Park
London SE5 8AF
England
                                       xxi

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Chapter 13:  Risk Assessment

Principal Authors

Dr. Lester Grant
Director, Environmental Criteria and
  Assessment Office
MD-52
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711

Contributing Authors

Dr. Robert Elias
Environmental Criteria and Assessment Office
MD-52
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711

Dr. Vic Hasselblad
Biometry Division
MD-55
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711
Dr. Dennis Kotchmar
Environmental Criteria and Assessment Office
MD-52
U.S. Environmental Protection Agency
Research Triangle Park, NC  27711
Dr. Paul Mushak
Department of Pathology
UNC School of Medicine
Chapel Hill, NC  27514
Dr. Alan Marcus
Department of Mathematics
Washington State University
Pullman, Washington  99164-2930
Dr. David Weil
Environmental Criteria and
  Assessment Office
U.S Environmental Protection
  Agency
Research Triangle Park, NC  27711
                                     xxn

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                           12.   BIOLOGICAL EFFECTS OF LEAD EXPOSURE
12.1  INTRODUCTION
     As noted  in Chapter 2,  air  quality criteria documents evaluate scientific  knowledge  of
relationships between pollutant concentrations and their effects on the  environment and  public
health.   Chapters 3-7  of  this document discuss the  following:   physical  and chemical proper-
ties  of  lead;  measurement  methods  for  lead in environmental  media;  sources of  emissions;
transport,  transformation, and  fate;  and ambient concentrations and other  aspects  of the ex-
posure of the  U.S.  population to lead  in  the environment.   Chapter 8  evaluates the projected
impact of  lead on  ecosystems.   Chapters 9-11 discuss the  following:   measurement  techniques
for lead in  biologic  media;  aspects related  to  the  uptake, distribution, toxicokinetics, and
excretion of lead; and the relationship of various external  and internal lead exposure  indices
to each other.   This  chapter  assesses  information regarding biological  effects of lead expo-
sure,  with  emphasis on (1) the qualitative characterization of various  lead-induced effects
and (2) the  delineation of dose-effect relationships for  key health  effects  most  likely  of
concern  at  ambient exposure  levels currently  encountered  by  the  general  population  of the
United States.
     It is clear  from the evidence evaluated in this chapter that there exists a continuum of
biological   effects  associated  with  lead  across a  broad  range of  exposure.   At  rather low
levels of  lead  exposure,  biochemical  changes,  such as the  disruption of  certain  enzymatic
activities involved in heme  biosynthesis and erythropoietic pyrimidine metabolism, are  detec-
table.  With increasing lead  exposure, there are sequentially more pronounced effects  on heme
synthesis and  a  broadening  of lead's  effects  to  additional  biochemical  and physiological
mechanisms  in  various tissues, such  that progressively more severe disruption of  the  normal
functioning  of many different  organ  systems becomes apparent.  In  addition  to impairment of
heme biosynthesis, signs of disruption of normal functioning of the erythropoietic and nervous
systems are  among the earliest effects observed  in  response to increasing lead exposure.  At
increasingly higher exposure  levels,  more severe disruption of the erythropoietic and nervous
systems occurs;  other  organ  systems are also affected so as to result  in the manifestation of
renal  effects,  disruption of  reproductive functions,  impairment  of immunological  functions,
and many other biological  effects.  At  sufficiently high levels of exposure, the damage to the
nervous system and  other  effects can be severe enough to result in death or, in some cases of
non-fatal lead poisoning,  long-lasting  sequelae such as permanent mental retardation.
     The etiologies of many of the different types of functional disruption of various mamma-
lian  organ  systems  derive (at  least  in their earliest stages) from lead's effects on certain
subcellular  organelles,  which  result  in biochemical  derangements (e.g.,  disruption of heme
                                            12-1

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synthesis  processes)  common  to and  affecting  many  tissues and  organ  systems.   Some  major
effects of  lead  on subcellular organelles common to  numerous organ systems in mammalian spe-
cies  are  discussed below in Section 12.2, with  particular emphasis on lead effects  on  mito-
chondrial functions.  Subsequent sections of this chapter discuss  biological  effects of lead
in terms  of various organ or physiological  systems affected by the element and its  compounds
(except for  Section 12.7,  which assesses genotoxic and  carcinogenic  effects  of lead).   Addi-
tional cellular and subcellular aspects of the biological effects of lead are discussed within
respective sections on particular organ systems.
     Sections  12.3 to 12.10  have  been  sequenced  generally  according to the  degree  of  known
vulnerability  of each system to lead.   Major  emphasis  is  placed first on detailed discussion
of  the  effects  of  lead on  heme  synthesis  and associated multisystem  impacts  on  several
important physiological  processes and organ systems.   Effects of lead on the two organ systems
classically  considered to  be most  sensitive to  lead  (i.e.,  the hematopoietic  and  the nervous
systems)  are further emphasized in  early sections.   Subsequent sections  then discuss  addi-
tional effects of   lead  on  the kidney  and on reproduction  and development (in  view of  the
impact of  lead on  the fetus and pregnant women,  as  well as its gametotoxic effects).   Geno-
toxic  effects  of  lead and  evidence for  possible carcinogenic  effects  of lead are  then  re-
viewed, followed by discussion of  the effects of lead on the immune system and, lastly,  other
organ systems.
     This chapter  is  subdivided mainly according to  organ systems  to facilitate  presentation
of information.  It must be noted, however,  that in reality, all systems function  in delicate
concert to  preserve the  physiological  integrity  of the whole organism and all  systems are in-
terdependent.   Thus,  not only  do  effects in  a  critical  organ often exert impacts  on  other
organ systems, but  low-level effects that might be construed as  unimportant in  a single speci-
fic system may be of concern in terms of their cumulative or aggregate impact.
     Special emphasis is placed on the discussion of the effects of lead exposure  in  children.
Children  are particularly  at risk  due to  sources of  exposure,  mode of entry,  rate of absorp-
tion and retention, and partitioning of lead in soft and hard tissues.  The greater sensitivi-
ty of  children to  lead  toxicity, their  inability to  recognize  symptoms,  and their dependence
on parents  and  health care professionals make  them  an especially  vulnerable population  re-
quiring special consideration in developing criteria and standards for lead.
     In discussing  the biological  effects of  lead, it  is  important to note that lead has not
been  demonstrated  to have  any beneficial biological  effect in humans.   Some recent studies
have raised  the possibility that lead could be a  nutritionally essential  element.   The primary
evidence for this view has come from a series of  articles by Kirchgessner and Reichlmayr-Lais,
who have  reported   that  rats maintained  on  a semi-synthetic diet  low in  lead (either  18 or
45 ppb)   over   several    generations   showed  reduced   growth   rates   (Reichlmayr-Lais  and
Kirchgessner,  1981a), disturbances  in  hematological  indices, tissue iron, and  iron absorption
                                           12-2

-------
(Reichlmayr-Lais  and Kirchgessner, 1981b,c,d,e;  Kirchgessner and  Reichlmayr-Lais,  1981a,b),
and  changes   in   certain   enzyme  activities  and  metabolite  levels  (Reichlmayr-Lais   and
Kirchgessner,  1981f;  Kirchgessner and  Reichlmayr-Lais,  1982).   Diets containing  18 ppb  lead
were associated with the most pronounced effects on  iron  metabolism and growth as well as on
enzyme activities  and  metabolite  levels.   Animals in the Fj-group maintained on a 45-ppb  lead
diet showed moderate changes in some hematological indices.
     These studies were reviewed by a committee of independent scientists convened by the  U.S.
Environmental  Protection  Agency  (Expert  Committee  on Trace  Metal  Essentiality,  1983).   The
Committee's conclusions were as follows:

     1.   The  Kirchgessner  and Reichlmayr-Lais data furnish  evidence  that is consistent
          with  and,  in  some  opinions,  indicative of a  nutritional  essentiality of lead
          for  rats.
     2.   The  evidence is  not  sufficient to  establish  nutritional  essentiality of lead
          for  rats.
     3.   To address the basic issue of nutritional essentiality of lead, additional evi-
          dence  needs  to  be  obtained  under  different  conditions  in the  laboratory of
          Kirchgessner  and  Reichlmayr-Lais,   as  well  as  by  independent investigators;
          additional species should also be examined.

     The  Committee  emphasized   the  difference  that  apparently  exists  between  lead  con-
centrations  that  are  of concern  from  a toxicologic  viewpoint (e.g.,  those  associated  with
effects of  the various types  discussed in this chapter) and  much lower  lead levels  that might
possibly  be  of nutritional  value.  Hence the Committee  did  not perceive  any practical incom-
patibility  between (a) efforts to reduce lead in the human environment  to concentrations that
are  unassociated  with  toxic  effects  and  (b) efforts  to define  the  potential   nutritional
essentiality  of  lead.   The Committee further  recognized  that  current public health concerns
for  humans clearly focus on lead  toxicity effects.
     Finally,  the question  of lead essentiality  is  largely moot in the debate  over lead as a
public health  issue.   The  extent of permanent and  pervasive lead contamination  in  developed
areas  of the  world  is  such  that concern will remain with  excessive  lead exposure and asso-
ciated toxicity in  human populations.   It  is virtually inconceivable that  lead deficiency in
human  populations would ever arise in the first place.
 12.2  SUBCELLULAR EFFECTS  OF  LEAD  IN  HUMANS  AND EXPERIMENTAL  ANIMALS
      The  biochemical or molecular basis  for lead toxicity is the  ability of the  toxicant,  as
 a metallic  cation,  to bind  to ligating  groups  in  biomolecular substances  crucial  to  normal
 physiological  functions,  thereby interfering  with  these functions  via  such  mechanisms  as
                                             12-3

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competition with native essential  metals for binding sites,  inhibition of enzyme activity,  and
inhibition or  other alterations of essential  ion  transport.   The relationship of  this  basis
for  lead  toxicity  to  organ-  and organelle-specific  effects  is  modulated  by  the  following:
(1) the  inherent  stability  of  such  binding  sites  for  lead;   (2) the  compartmentalization
kinetics governing lead distribution among body compartments,  among tissues,  and within cells;
and (3) differences in biochemical  and physiological organization across tissues and cells  due
to their  specific  function.   Given  complexities introduced by factors 2 and  3,  it is not sur-
prising that  no single,  unifying  mechanism of  lead  toxicity has been  demonstrated  to  apply
across all tissues and organ systems.
     In the 1977  Air  Quality  Criteria Document  for Lead,  cellular and subcellular effects of
lead were  discussed,  including  effects on various classes of  enzymes.   Much  of the literature
detailing  the  effects  of  lead on enzymes per se has entailed  study of relatively pure enzymes
iji vitro  in the presence  of added  lead.   This  was the case for data discussed in the earlier
document and such information continues to appear in the literature.   Much of this material is
of questionable relevance for  effects of lead  In  vivo.   On  the other  hand,  lead effects on
certain enzymes  or  enzyme systems are recognized  as  integral  mechanisms of action underlying
the  impact of  lead on tissues  in vivo and are  logically discussed in later sections below on
effects at the organ system level.
     This  subsection  is  mainly  concerned with  organellar  effects of  lead,  especially those
that provide  some  rationale  for  lead  toxicity at higher  levels of  biological organization.
While  a common mechanism  at the subcellular  level  that would account for all aspects of lead
toxicity  has  not been identified, one  fairly  common  cellular response to lead is the impair-
ment of mitochondrial  structure and function;  thus,  mitochondrion  effects  are accorded major
attention  here.   Lead  effects  on other  organelles have not  been as  extensively studied as
mitochondrion  effects; in  some  cases, it  is  not clear how  the available  information,  e.g.,
that on lead-containing nuclear inclusion bodies, relates to organellar dysfunction.

12.2.1 Effects of  Lead on the Mitochondrion
     The  mitochondrion is clearly the target organelle for toxic effects of lead on many tis-
sues,  the characteristics of"vulnerability varying somewhat  with cell  type.   Given early re-
cognition  of  this sensitivity,  it is  not  surprising  that an  extensive body of i_n vivo and j_n
vitro  data has accumulated, which  can be characterized as evidence  of the  following:   (1)
structural injury to the  mitochondrion;  (2) impairment of basic  cellular energetics and other
mitochondrial  functions;  and  (3) uptake of lead by mitochondria jji vivo and in vitro.
12.2.1.1   Lead Effects on Mitochondrial  Structure.   Changes  in  mitochondrial  morphology with
lead exposure  have  been well documented in humans and experimental animals and, in the case of
the  kidney, are a rather early response to such exposure.  Earlier studies have been  reviewed
by Goyer and Rhyne  (1973), followed by later updates by Fowler (1978) and Bull  (1980).
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     Chronic oral exposure  of  adult rats to lead  (1  percent  lead acetate in  diet)  results  in
structural changes in renal  tubule mitochondria,  including swelling with distortion  or  loss  of
cristae (Goyer,  1968).   Such  changes have also been documented in renal biopsy tissue  of  lead
workers (Wedeen  et  al.,  1975;  Biagini et al., 1977)  and in tissues other than  kidney,  i.e.,
heart (Malpass et al., 1971; Moore et al., 1975b), liver (Hoffmann et al., 1972), and the  cen-
tral (Press, 1977) and peripheral (Brashear et al., 1978) nervous systems.
     While it appears that relatively high-level  lead exposures are necessary  to detect struc-
tural changes  in mitochondria  in some  animal models (Goyer,  1968;  Hoffmann et al.,  1972),
changes in  rat  heart  mitochondria  have  been  seen at  blood  lead levels as  low as 42 ug/dl.
Also, in  the study of Fowler  et al.  (1980),  swollen mitochondria in renal tubule  cells  were
seen in rats chronically exposed to  lead from gestation to 9 months of age at a dietary lead
dosing level as  low as 50 ppm and a median blood lead level of 26 ug/dl  (range:  15-41  ug/dl).
Taken collectively,  these  differences point out relative tissue sensitivity,  dosing protocol,
relative  sensitivity  of the  various experimental  techniques,  and  the  possible   effect  of
developmental  status  (Fowler  et al., 1980) as important factors in determining lead exposure
levels at which  mitochondria are  affected in various tissues.
12.2.1.2   Lead Effects on Mitochondria!  Function.   Both in vivo  and in vitro studies  dealing
with  such effects  of  lead  as  the  impact on energy  metabolism,  intermediary metabolism, and
intracellular  ion  transport have been carried out  in various experimental  animal models.  Of
particular  interest for this  section are  such  effects of lead  in  the developing  versus the
adult animal,  given the  greater  sensitivity of the young organism to lead.
12.2.1.3   In Vivo Studies.  Uncoupled energy metabolism, inhibited cellular respiration using
succinate  and  nicotinamide  adenine dinucleotide  (NAD)-linked substrates, and altered kinetics
of  intracellular calcium have all   been  documented for  animals  exposed to  lead jn vivo,  as
reviewed  by  Bull (1980).
     Adult  rat kidney  mitochondria,  following chronic oral  feeding of lead in the diet (1 per-
cent lead acetate,  10  or more  weeks)  showed a marked  sensitivity  of the pyruvate-NAD reductase
system  (Goyer, 1971),  as indicated  by impairment of  pyruvate-dependent respiration  indexed by
AOP/0  ratio and respiratory  control rates  (RCRs).   Succinate-mediated  respiration in these
animals,  however, was  not different  from controls.   In contrast,  Fowler et al. (1980) found in
rats exposed jn utero (dams fed 50 or 250 ppm  lead)  and for 9 months postnatally  (50 or 250
ppm lead  in  their diet)  renal  tubule mitochondria  that exhibited  decreased state 3  respiration
and RCRs  for both  succinate and pyruvate/malate substrates.  This may  have been due to longer
exposure  to  lead or a  differential  effect of  lead exposure  during early development.
     Intraperitoneal  administration of  lead to  adult rats  at doses  as  low as  12 mg/kg over 14
days  was  associated  with  inhibition of potassium-stimulated  respiration  in cerebral cortex

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slices  with impairment of  NADPH (NAD  phosphate,  reduced) oxidation  using  glucose, but  not
pyruvate, as  substrate (Bull  et al.,  1975).   This  effect occurred at a  corresponding  blood
lead  of 72  ug/dl  and a brain  lead content  of 0.4  ug/g, values below those  associated with
overt  neurotoxicity.   Bull  (1977),  in  a later study,  demonstrated that  the  respiratory  re-
sponse  of  cerebral cortical  tissue from lead-dosed  rats receiving a  total  of 60  mg/kg  (10
mg/kg  x  6 dosings) over 14 days was  associated with a marked decrease in turnover  of  intra-
cellular calcium  in  a  cellular  compartment  that  appears to be  the mitochondrion.   This  is
consistent  with  the  observation  of Bouldin  et al.  (1975) that  lead  treatment leads to  in-
creased retention of calcium in guinea pig brain.
     Numerous studies  have  evaluated relative effects of  lead on  mitochonodria of developing
versus  adult  animals, particularly in  the  nervous  system.   Holtzman and  Shen  Hsu (1976)  ex-
posed  rat pups  at 14 days of  age  to lead via milk of mothers fed lead in the diet (4 percent
lead  carbonate) with  exposure lasting for 14 days.   A 40 percent increase in state 4 respira-
tory rate of cerebellar mitochonodria was seen within one day of treatment and was  lost at the
end of the exposure period.   However, at this later time (28 days of age), a  substantial  inhi-
bition of state 3 respiration was observed.   This early effect of lead  on uncoupling  oxidative
phosphorylation  is consistent with the  results of  Bull  et  al.   (1979)  and  McCauley et  al.
(1979).  In these investigations,  female rats  received  lead  in  drinking  water (200  ppm) from
14  days before breeding  through weaning of  the pups.   At 15 days of age,  cerebral  cortical
slices  showed alteration  of  potassium-stimulated  respiratory  response   and  glucose uptake.
     Holtzman et  al.  (1980a)  compared mitochondrial  respiration in cerebellum and  cerebrum in
rat pups exposed  to lead beginning at  14 days  of age (via milk of mothers fed 4 percent lead
carbonate)  and  in adult rats  maintained on the same diet.   Cerebellar mitochondria  showed a
very  early  loss  (by 2 days of exposure) of respiratory control  in the  pups with inhibition of
phosphorylation-coupled  respiration  for  NAD-1inked  substrates but  not  for  succinate.   Such
changes  were  less  pronounced  in mitochondria  of  the cerebrum  and  were  not  seen  for  either
brain  region  in  the adult rat.  This regional-and age-dependency  of mitochondrial  impairment
parallels features of  lead encephalopathy.
      In  a second  study addressing this  issue,  Holtzman  et al.  (1981)  measured the cytochrome
contents of cerebral  and cerebellar mitochondria from rat pups exposed  either from  birth or at
14  days of age via the same dosing protocol  noted above.   These were compared to adult animals
exposed  in  like  fashion.   Pups  exposed  to  lead from birth  showed  statistically  significant
reductions  of  cytochrome b,  cytochromes c  + clf and  cytochromes a + a3 in  cerebellum by 4
weeks  of exposure.   Changes  in  cerebral cytochromes, in contrast, were  marginal.   When lead
exposure began  at  14  days  of age,  little  effect was observed, and adult rats showed  little
change.  This study  indicates that the most  vulnerable  period  for lead effects on developing
brain  oxidative  metabolism  is the  same  period where a major burst in such  activity begins.

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     Related to effects of lead on energy metabolism in the developing animal  mitochondrion  is
the effect on  brain  development.   In the study of  Bull  et al.  (1979) noted earlier,  cerebral
cytochrome c +  cx  levels between 10 and  15  days  of age decreased in a dose-dependent fashion
at all maternal  dosing levels (5-100 mg Pb/liter drinking water) and corresponding blood lead
values for the  rat  pups (11.7-35.7 ug/dl).   Delays  in synaptic  development in these pups also
occurred, as  indexed by  synaptic  counts taken in  the parietal  cortex.  As  the  authors  con-
cluded, uncoupling of  energy  metabolism appears to be  causally  related to delays in cerebral
cortical  development.
     Consistent with the  effects  of lead on mitochondrial  structure  and function are i_n vivo
data demonstrating the  selective  accumulation  of lead in mitochondria.  Studies in rats using
radioisotopic  tracers  210Pb  (Castellino  and Aloj,  1969)  and 203Pb  (Barltrop et  al.,  1971)
demonstrate that mitochondria will accumulate lead in significant relative amounts, the nature
of the accumulation  seeming to vary with the  dosing  protocol.   Sabbioni and Marafante (1976)
as well  as  Murakami  and Hirosawa  (1973)  also  found that lead is selectively lodged  in mito-
chondria.  Of  interest in regard to the effects of lead on brain mitochondria are the data  of
Moore et  al.  (1975a) showing uptake of  lead by guinea pig cerebral mitochondria, and the re-
sults of Krigman et al. (1974c) demonstrating that mitochondria in brain from 6-month-old rats
exposed chronically  to  lead since birth  showed the  highest uptake  of lead (34 percent), fol-
lowed  by  the nuclear  fraction  (31 percent).   While the possibility  of  translocation of lead
during subcellular fractionation  can be raised, the  distribution pattern seen in the reports
of Barltrop  et al.  (1971) and Castellino and Aloj (1969) over multiple time points makes this
unlikely.  Also,  findings of jji vivo uptake of lead in brain mitochondria are supported by jn
vitro data discussed below.
12.2.1.4  In Vitro Studies.    In  vitro studies of both the response of mitochondrial function
to  lead  and its accumulation by  the organelle have been  reported,  using both isolated mito-
chondria and tissues.  Bull (1980) reviewed such data published up to  1979.
     Significant reductions  in  mitochondrial  respiration,  using both  NAD-linked and  succinate
substrates,  have  been  reported for  isolated heart  and brain mitochondria.   The lowest levels
of  lead  associated  with  such effects appear  to  be 5 uM or, in  some cases,  less.  Available
evidence  suggests  that the  sensitive  site  for lead in  isolated  mitochondria is  before cyto-
chrome b in the  oxidative chain  and  involves either  tricarboxylic  acid enzymes or non-heme
protein/ubiquinone steps.   If substrate specificity is compared, e.g.,  succinate  versus glut-
amate/malate oxidation,  there appear to  be organ-specific  differences.   As Bull  (1980) noted,
tissue-specific  effects of  lead  on cellular  energetics may be  one  basis for differences in
toxicity  across organs.   Also,  several enzymes  involved  in  intermediary  metabolism in isolated
mitochondria have  been observed to  undergo significant  inhibition of  activity  in  the presence
of lead;  these  have  been  tabulated by Bull (1980).
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     One  focus  of studies  dealing  with  lead  effects on  isolated  mitochondria has  been  ion
transport—particularly that  of calcium.  Scott  et  al.  (1971) have shown that  lead  movement
into rat  heart  mitochondria involves active transport, with characteristics  similar  to those
of  calcium,  thereby  establishing a  competitive relationship.   Similarly,  lead uptake  into
brain mitochondria is  also  energy-dependent (Holtzman et al., 1977; Goldstein  et al.,  1977).
The  recent  elegant studies of  Pounds and  coworkers (Pounds et al., 1982a,b),  using  labeled
calcium or  lead and  desaturation kinetic studies of these labels in isolated rat hepatocytes,
have elucidated the  intracellular relationship of  lead  to calcium in terms  of  cellular  com-
partmentalization.  In the presence  of graded amounts of lead (10,  50,  or 100 uM),  the kinetic
analysis  of  desaturation  curves  of  4SCa label  showed a lead dose-dependent increase  in  the
size of all  three calcium compartments within the hepatocyte,  particularly that deep  compart-
ment associated with the  mitochondrion (Pounds et al.,  1982a).   Such  changes were  seen to be
relatively independent  of serum  calcium  or endogenous regulators of systemic  calcium  metab-
olism.   Similarly,  the use of  210Pb label and  analogous kinetic  analysis  (Pounds  et  al.,
1982b)  showed the  same  three  compartments of intracellular distribution  as noted for  calcium,
including  the deep component  A:  redundant.   Hence,  there  is striking  overlap in the  cellular
metabolism of calcium  and  lead.  These studies  not  only further confirm easy  entry of  lead
into cells  and  cellular  compartments,  but also  provide  a basis for perturbation by lead of
intracellular ion transport, particularly  in  neural  cell mitochondria, where there is  a  high
capability for  calcium transport.   Such  capability  is  approximately  20-fold  higher than in
heart mitochondria (Nicholls,  1978).
     Given the  above  observations,  it is not  surprising that  a number of  investigators  have
noted the jji vitro uptake of  lead into  isolated  mitochondria.   Walton  (1973) noted that  lead
is  accumulated  within  isolated  rat  liver  mitochondria  over  the range  of  0.2-100 uM  lead;
Walton and  Buckley (1977)  extended  this observation  to mitochondria  in rat kidney  cells in
culture.   Electron microprobe analyses  of isolated  rat synaptosomes (Silbergeld et  al.,  1977)
and capillaries  (Silbergeld et  al.,  1980b)  incubated with lead ion have  established that  sig-
nificant  accumulation of  lead,  along with calcium,  occurs in the mitochondrion.   These  obser-
vations are  consistent  with the kinetic studies  of  Pounds  et  al.  (1982a,b),  and the  in vitro
data for  isolated capillaries are in accord with the observations of Toews et al.  (1978),  who
found significant lead accumulation  in brain capillaries of the suckling  rat.

12.2.2  Effects  of Lead on the Nucleus
     With  lead exposure, a cellular  reaction typical  of many species (including  humans)  is the
formation  of  intranuclear  lead-containing  inclusion  bodies, early  data  for which have  been
summarized  by  Goyer  and  Moore  (1974).   In  brief,  these lead-bearing  inclusion  bodies  A:
(1) have  have been verified as  to lead content by X-ray microanalysis  (Carroll  et al.,  1970);
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(2) consist of a  rather  dense core encapsulated by  a  fibrillary envelope;   (3) are a complex
of lead and the acid fractions of nuclear protein;   (4) can be disaggregated jin vitro by EDTA;
(5) can appear very  rapidly  after lead exposure (Choie  et  al.,  1975);   (6) consist of a pro-
tein moiety  in the  complex  which is  synthesized  de  novo;  and  (7) have  been  postulated  to
serve a protective  role  in the cell,  given  the  relative amounts of lead accumulated and pre-
sumably rendered lexicologically inert.
     Based on  renal biopsy  studies,  Cramer  et al.  (1974) concluded that such inclusion body
formation in renal tubule cells in lead workers is an early response to lead entering the kid-
ney, in view  of  decreased presence of  the  inclusion bodies as a function of increased period
of  employment.   Schumann et  al.  (1980),  however,  observed a continued  exfoliation of inclu-
sion-bearing tubule cells into urine of workers having a variable employment history.
     Any protective  role  played by the lead inclusion body appears to be an imperfect one,  to
the  extent  that both  subcellular  organelle  injury and  lead  uptake  occur  simultaneously with
such inclusion formation, often in association with severe toxicity at the organ system level.
For  example,  Osheroff  et al.  (1982)  observed lead inclusion bodies in the anterior horn cells
of  the  cervical  spinal cord and neurons  of  the substantia nigra (as well  as  in renal tubule
cells) in the adult rhesus monkey, along with damage to the vascular walls and glial processes
and  ependymal  cell  degeneration.   At the light- and electron-microscope level, there were no
signs  of  neuronal  damage  or altered  morphology except for the  inclusions.   As noted by the
authors,  these inclusions in the  large neurons  of the  substantia  nigra  show  that the neuron
will take  up  and accumulate  lead.   In  the  study of Fowler et al. (1980),  renal tubule inclu-
sions  were  observed simultaneously  with evidence of  structural  and  functional  damage to the
mitochondrion,  all  at relatively  low  levels of lead.   Hence, it appears  that a limited pro-
tective role  for these inclusions  may extend across a  range of lead exposure.
     Chromosomal effects and  other indices of genotoxicity  in humans and animals are  discussed
in  Section 12.7 of  this chapter.

12.2.3  Effects of  Lead on Membranes
     In theory, the  cell membrane  is  the  first organelle to encounter lead,  and  it  is not sur-
prising  that cellular effects  can be  ascribed  to  interactions  at cellular and intracellular
membranes,  mainly appearing  to be associated with  ion transport processes across  membranes.
In  Section  12.3 a more detailed discussion  is  accorded the effects  of  lead on the  membrane as
they relate  to the  erythrocyte  in terms  of  increased  cell  fragility  and increased  osmotic  re-
sistance.  These  effects can be  rationalized,  in  large part, by the documented inhibition by
lead of erythrocyte membrane (Na  , K )-ATPase.
     Lead also appears to  interfere  with the normal  processes of calcium transport  across mem-
branes  of  various  tissue  types.    Silbergeld  and  Adler  (1978)  have  described  lead-induced
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retardation of the  release  of the neurotransmitter, acetylcholine,  in  peripheral  cholinergic
synaptosomes,  due  to a  blockade of  calcium  binding to  the synaptosomal membrane,  reducing
calcium-dependent choline uptake  and  subsequent release of  acetylcholine from  the nerve ter-
minal.   Calcium  efflux  from neurons  is  mediated  by the membrane (Na , K )-ATPase via  an ex-
change  process with  sodium.   Inhibition  of  the  enzyme  by lead,  as  also  occurs with  the
erythroctye (see above),  increases  the concentration of calcium within  nerve endings (Goddard
and  Robinson,  1976).   As seen  from the data  of  Pounds  et al.  (1982a),  lead can  also  elicit
retention of calcium in  neural cells by easy entry into the cell and by  directly affecting the
deep  calcium  compartment within  the  cell, of which the mitochondrion is a  major component.

12.2.4  Other Organellar Effects of Lead
     Studies  of  morphological  alterations  of renal tubule  cells in the rat  (Chang et al.  ,
1981)  and  rabbit (Spit  et  al.,   1981)  with varying lead  treatments have  demonstrated lead-
induced  lysosomal  changes.   In  the rabbit,  with  relatively modest  levels  of  lead exposure
(0.25  or 0.5  mg/kg,  3 times weekly over  14 weeks) and corresponding blood  lead values of 50
and  60  ug/dl,  there  was  a dose-dependent increase in the amount of lysosomes in proximal con-
voluted tubule cells, as well  as increased numbers of lysosomal  inclusions.   In the rat, expo-
sure  to 10 mg/kg  i.v.  (daily over 4  weeks)  resulted  in the accumulation of lysosomes, some
gigantic, in  the pars recta segment of  renal  tubules.   These  animal data are consistent with
observations  made  in lead  workers  (Cramer et al.,  1974;  Wedeen et al., 1975)  and  appear to
represent a disturbance  in normal lysosomal function, with the accumulation of lysosomes being
due  to enhanced degradation  of  proteins  arising  from effects  of  lead  elsewhere within the
cell.

12.2.5  Summary of Subcellular Effects of Lead
     The biological basis of lead toxicity  is  closely linked to the ability of lead to bind to
ligating groups  in biomolecular  substances crucial to  normal  physiological  functions.  This
binding  interferes  with  physiological  processes by  such mechanisms  as  the following:  compe-
tition  with native  essential  metals for binding sites, inhibition of enzyme activity, and in-
hibition or other changes in essential ion  transport.
      The main  target organelle for lead toxicity in  a variety of cell and tissue types clearly
is  the mitochondrion, followed  probably by  cellular  and  intracellular membranes.  Mitochon-
dria!  effects take  the  form of  structural changes and  marked disturbances in mitochondrial
function within  the cell, especially energy  metabolism  and  ion transport.   These effects are
associated,  in turn,  with demonstrable accumulation of lead in mitochondria, both in vivo and
HI  vitro.   Structural changes  include  mitochondrial swelling in many  cell  types, as well as

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distortion and  loss of cristae, which  occur  at relatively moderate levels of  lead  exposure.
Similar changes have  been  documented in lead workers  across  a wide range of  exposure levels.
     Uncoupled energy metabolism,  inhibited  cellular respiration using both succinate and n1-
cotinamide adenine dinucleotide (NAD)-linked substrates, and altered kinetics  of intracellular
calcium have  been  demonstrated i_n vivo using mitochondria of brain and non-neural  tissue.   In
some cases,  relatively  moderate lead exposure  levels  have  been associated with such changes,
and  several  studies  have  documented  the  relatively greater sensitivity of this organelle  in
young versus  adult animals in terms of mitochondrial  respiration.   The cerebellum appears to
be  particularly  sensitive, providing  a connection between mitochondrial  impairment and lead
encephalopathy.   Impairment by lead of mitochondrial function in the developing brain has also
been associated with  delayed  brain development, as indexed by content of various cytochromes.
In  the  rat pup,  ongoing lead exposure from birth is required for this effect to be expressed,
indicating that such  exposure must occur before, and is inhibitory to, the burst of oxidative
metabolism activity that normally occurs in the young rat 10-21 days postnatally.
     Jji vivo  lead  exposure of adult rats  has  also been observed to markedly inhibit cerebral
cortex  intracellular  calcium  turnover (in a cellular compartment that appears to be the mito-
chondrion)  at a brain  lead level  of  0.4  ppm.   These results  are  consistent with a separate
study  showing increased  retention  of calcium  in  the brains  of  lead-dosed guinea  pigs.   A
number  of reports  have described the jji  vivo  accumulation of  lead in mitochondria of kidney,
liver,  spleen,  and brain  tissue,  with  one  study showing that  such  uptake was slightly more
than occurred in the  nucleus.  These data are not only consistent with the various deleterious
effects of lead on mitochondria but are also supported by other, i_n vitro findings.
     Significant  decreases in  mitochondrial  respiration jji  vitro,  using both NAD-linked and
succinate substrates, have been observed for  brain  and non-neural tissue mitochondria  in the
presence  of  lead at micromolar  levels.  There appears  to be substrate  specificity  in  the inhi-
bition  of respiration  across  different tissues, which may be  a factor in differential organ
toxicity.  Also, a number  of  enzymes  involved  in intermediary  metabolism  in isolated  mitochon-
dria have been observed to  undergo  significant  inhibition of  activity  with  lead.
     A  major focus of  research  on lead effects  on isolated  mitochondria  has concerned ion
(especially  calcium)  transport.   Lead movement  into  brain  and other tissue mitochondria, as
does  calcium movement,  involves  active transport.   Recent sophisticated kinetic analyses of
desaturation  curves for radio!abeled lead or  calcium indicate that there  is striking overlap
in  the  cellular metabolism of  calcium  and lead.   These  studies not only  establish a basis for
easy  entry of lead into cells  and cell compartments, but  also provide a basis for  impairment
by  lead  of  intracellular  ion transport, particularly  in  neural cell mitochondria,  where the
capacity  for  calcium  transport is 20-fold  higher than even  in heart mitochondria.
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     Lead is  also  selectively taken up in isolated mitochondria rn vitro, including the mito-
chondria of synaptosomes  and brain capillaries.   Given the  diverse  and extensive evidence of
lead's impairment  of  mitochondrial  structure and function as viewed from a subcellular level,
it is not surprising that these derangements are logically held to be the basis of dysfunction
of heme  biosynthesis,  erythropoiesis,  and the central nervous system.   Several key enzymes in
the heme biosynthetic  pathway are intramitochondrial, particularly ferrochelatase.   Hence, it
is to be expected  that entry of lead into mitochondria will  impair overall heme biosynthesis,
and in fact this appears to be the case in the developing cerebellum.   Furthermore,  the levels
of lead  exposure associated with entry of  lead  into mitochondria and expression of mitochon-
drial injury can be relatively moderate.
     Lead exposure  provokes a typical cellular  reaction  in  human and other species  that  has
been morphologically characterized  as  a  lead-containing nuclear  inclusion  body.  Although it
has been postulated that such  inclusions  constitute a cellular protection mechanism,  such  a
mechanism is  an  imperfect  one.   Other organelles, e.g.,  the mitochondrion,  also take up lead
and sustain injury  in the presence of nuclear inclusion bodies.   Chromosomal effects and other
indices of  genotoxicity in humans and animals are considered  later, in Section  12.7.
     In theory, the cell  membrane is the first organelle to  encounter lead and it is not sur-
prising that  cellular  effects of lead can be  ascribed  to interactions at cellular and intra-
cellular membranes  in the   form  of disturbed  ion  transport.   The  inhibition of  membrane
(Na ,K )-ATPase of  erythrocytes as  a  factor  in  lead-impaired  erythropoiesis   is  noted else-
where.   Lead  also  appears  to interfere with the  normal  processes of calcium transport across
membranes of  different tissues.   In peripheral  cholinergic synaptosomes,  lead is  associated
with retarded release of acetylcholine owing to a blockade of calcium binding to the membrane,
while calcium accumulation within  nerve endings can  be ascribed  to  inhibition of  membrane
(Na+,K+)-ATPase.
     Lysosomes accumulate in  renal  proximal  convoluted tubule cells of rats and rabbits given
lead over a wide range of dosing.   This  also  appears to occur in the kidneys  of lead workers
and seems  to  represent a disturbance  in  normal  lysosomal function, with  the  accumulation of
lysosomes being due  to enhanced degradation of proteins  because  of the effects of lead else-
where within the cell.
     Insofar  as effects  of  lead on the activity of various enzymes are concerned, many of the
available studies concern uj vitro behavior of relatively pure enzymes with marginal relevance
to various effects  jji vivo.   On the other  hand,  certain enzymes are  basic  to the  effects of
lead at  the organ  or organ system  level,  and  discussion is  best reserved for  such effects in
ensuing sections of the document dealing with these systems.
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12.3  EFFECTS OF LEAD ON HEME BIOSYNTHESIS AND ERYTHROPOIESIS/ERYTHROCYTE PHYSIOLOGY  IN  HUMANS
      AND ANIMALS
     Lead has well-recognized  effects  not only on heme biosynthesis,  a crucial  process  common
to many organ systems, but also on the formation and physiology of erythrocytes.   This  section
is  therefore  divided for purposes of discussion  into  the following:   (1) effects of lead  on
heme  biosynthesis  including  discussion  of interrelationships  between heme biosynthesis  im-
pairment and  (a)  interference with vitamin-D metabolism and (b) certain neurotoxic effects  of
lead; and (2) effects of lead on erythropoiesis and erythrocyte physiology.   Discussion  of the
latter  is  further subdivided  into  effects  of lead on  hemoglobin  production,  cell  morphology
and survival, and erythropoietic nucleotide metabolism.

12.3.1  Effects of Lead on Heme Biosynthesis
     The effects of  lead on heme biosynthesis are very well known because of their prominence
and the large number of studies of these effects in humans and experimental  animals.   In addi-
tion to  being a constituent of hemoglobin, heme  is a prosthetic  group  of  a number  of tissue
hemoproteins  having  diverse  functions,  such  as myoglobin, the P-450  component  of  the  mixed-
function oxidase  system, and  the  cytochromes of cellular  energetics.   Hence,  any  effects  of
lead on heme biosynthesis will, perforce, pose the potential for multi-organ toxicity.
     At present, much of the available information concerning the  effects of lead on heme bio-
synthesis has  been  obtained by measurements  in  blood,  due in large part to the relative ease
of  access to  blood  and in  part to the fact  that blood is  the vehicle for movement of metabo-
lites  from  other  organ systems.   On the  other hand,  a number of  reports  have been concerned
with  lead effects  on heme  biosynthesis  in  tissues  such as kidney, liver,  and  brain.   In the
discussion  below, various  steps  in the heme  biosynthetic  pathway  affected by lead are discus-
sed  separately, with  information  describing  erythropoietic  effects  usually appearing first,
followed by studies  involving  other tissues.
     The process  of  heme biosynthesis results  in formation of a porphyrin,  protoporphyrin IX,
starting with glycine and  succinyl-coenzyme  A.   Heme  biosynthesis culminates with the inser-
tion of  iron  at the  center  of  the porphyrin ring.   As may  be  noted in  Figure 12-1, lead inter-
feres  with  heme biosynthesis by disturbing the activity of three  major enzymes:  (1) it in-
directly  stimulates, by feedback  derepression,  the mitochondria! enzyme delta-aminolevulinic
acid  synthetase (ALA-S), which mediates  the condensation  of glycine and  succinyl-coenzyme A to
form  delta-aminolevulinic  acid (ALA);  (2) it directly  inhibits  the cytosolic enzyme delta-
aminolevulinic  acid  dehydrase (ALA-D), which catalyzes  the cyclocondensation of two units of
ALA to  porphobilinogen;  (3)  it  disturbs  the mitochondrial  enzyme  ferrochelatase,  found in
                                            12-13

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                                     MITOCHONDRION
                                MITOCHONDRIA!. MEMBRANE
                         GLYCINE
                            -f
                       SUCCINYL-CoA
                       HEME
                              ALA SYNTHETASE
                                 (INCREASE)
                                                 FERRO-
                                                CHELATASE
                                            IRON+PROTOPORPHYRIN
                                                          I
                                   Pb (DIRECTLY OR          1
                                  BY DEREPRESSION)         *
                    AMINOLEVULINIC ACID
                           (ALA)
                                    IRON
                     ALA
                  DEHYDRASE
                  (DECREASE)
Pb
                                                             •Pb
                  COPROPORPHYRIN
                     (INCREASE)
                     PORPHOBILINOGEN
                       Figure 12-1.  Effects of lead (Pb) on heme biosynthesis.
liver, bone  marrow,  and other tissues, either by direct  inhibition or by  alteration  of  intra-
mitochondrial transport of iron.  Ferrochelatase catalyzes the  insertion of  iron  (II)  into  the
protoporphyrin  ring  to form heme and  is  situated in mammals  in  the  inner mitochondrial mem-
brane (McKay et al., 1969).
12.3.1.1  Effects of Lead on Delta-Aminolevulim'c Acid Synthetase.  The activity  of the  enzyme
ALA-S is  the rate-limiting step in the heme biosynthetic pathway.  With decreased heme  forma-
tion at  other  steps  downstream or with  increased  heme oxygenase activity, a compensatory  in-
crease of ALA-S activity occurs through  feedback derepression and enhances  the  rate of heme
formation.  Hence, excess ALA formation is due to both stimulation of ALA-S and direct inhibi-
tion of ALA-D (see below).
     Increased ALA-S activity has been reported in lead workers (Takaku et al., 1973;  Campbell
et  al.,  1977;  Meredith  et al. , 1978),  with leukocyte  ALA-S  reported to  be stimulated at  a
blood lead value  of  40 ug/dl (Meredith et al., 1978), a  level  at which ALA-D activity is sig-
nificantly inhibited.   To the  extent that mitochondria in leukocytes show a dose-effect rela-
tionship  comparable to the bone marrow and hepatic systems, it  appears that most  of the  excess
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ALA  formation below  the  observed  threshold  value is  due  to  ALA-D  inhibition.   From  the
authors'  data, blood ALA had increased about twofold in a subset of the worker population over
the blood lead range of 18-40 ug/dl.
     In vitro and j_n  vivo experimental data have  provided  organ-specific  results in terms of
the direction of the effect of lead on ALA-S activity.   Silbergeld et al.  (1982) observed that
ALA-S activity was  increased in kidney with acute lead exposure in rats,  while chronic treat-
ment was associated with increased activity of the enzyme in spleen.   In liver, however, ALA-S
activity was  reduced  under both acute and chronic dosing.  Fowler et al.  (1980) reported that
renal ALA-S  activity  was significantly reduced in rats continuously exposed to lead _m utero,
through development,  and up to 9 months of age.   Meredith and Moore (1979) noted a steady in-
crease  in  hepatic  ALA-S  activity  when rats  were given lead  parenterally over  an extended
period of  time.   Maxwell  and Meyer  (1976)  and Goldberg et al.  (1978)  also noted increased
ALA-S  activity  in  rats  given lead  parenterally.   It  appears that the type  and timeframe of
dosing influence  the  observed effect of lead  on  the enzyme activity.  Using a rat liver cell
line  (RLC-GAI)  in culture, Kusell et  al.  (1978)  demonstrated that lead could produce a time-
dependent  increase  in ALA-S activity.  Stimulation of activity was observed at lead levels as
low  as  5  x  10    M,  with maximal stimulation at 1 x 10*  M.   The  authors reported that the
increase in  activity was  associated with  the biosynthesis  of  more enzyme  rather than with
stimulation  of  the  pre-existing enzyme.  Lead-stimulated ALA-S  formation was also  not limited
to liver cells; rat gliomas  and mouse  neuroblastomas showed similar results.
12.3.1.2   Effects of  Lead  on Delta-Aminolevulinic Acid Dehydrase and Delta-Aminolevulinic Acid
Accumulati on/Excreti on.    Delta-aminolevulinic  acid dehydrase   (5-aminolevulinate   hydrolase;
porphobilinogen  synthetase; E.G.  4.2.1.24; ALA-D)  is  a sulfhydryl, zinc-requiring  allosteric
enzyme  in  the heme biosynthetic  pathway that  catalyzes the conversion of  two  units of  ALA to
porphobilinogen.  The enzyme's activity  is very sensitive to  inhibition by  lead,  but the inhi-
bition  is  reversed by reactivation  of  the sulfhydryl  group with agents such  as  dithiothreitol
(Granick  et  al.,  1973),  zinc  (Finelli  et al., 1975),  or  zinc plus glutathione (Mitchell et
al.,  1977).
      The activity of ALA-D  appears  to be  inhibited at virtually all  blood  lead levels  studied
so  far,  and  any  threshold  for  this effect remains to  be  identified (see discussion  below).
Dresner  et al.  (1982)  found that ALA-D activity  in rat bone marrow suspensions was  signifi-
cantly  inhibited  to 35 percent of control  levels  in the presence  of  5  x  10   M (0.5 |jM) lead.
This  potency was unmatched  on  a  comparative molar basis by  any other metal tested.  Recently,
Fujita  et  al.  (1981) showed evidence of an  increase in  the  amount of ALA-D in erythrocytes in
lead-exposed rats  that  was ascribed  to an increased  rate  of  ALA-D synthesis  in  bone  marrow
cells.   Hence,  the commonly  observed  net  inhibition of  activity occurs even  in the face of an
increase in  ALA-D synthesis.
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     Hernberg and  Nikkanen  (1970)  found  that enzyme  activity  was correlated  inversely  with
blood lead values  in  a group of urban,  nonexposed subjects.   Enzyme activity was inhibited 50
percent at a  blood lead level  of  16  ug/dl.   Other reports have confirmed  these observations
across age groups and exposure categories (Alessio et al.,  1976b;  Roels et al.,  1975b;  Nieburg
et al., 1974; Wada et al.,  1973).   A ratio of activated to  inhibited enzyme activity (versus a
single activity measurement, which does  not accommodate intersubject genetic variability)  mea-
sured  against children's  blood  lead values of  20-90 ug/dl  was  employed  by Granick et  al.
(1973) to obtain an estimated threshold  of 15 ug/dl for an  effect  of lead.   On the other  hand,
Hernberg and  Nikkanen  (1970)  observed no threshold  in their  subjects, all of whom were  at or
below 16 ug/dl.   Note  that the lowest blood  lead actually measured by Granick  et  al.  (1973)
was higher than the values  measured by Hernberg and Nikkanen (1970).
     Kuhnert  et  al.  (1977)  reported  that ALA-D  activity  measures in  erythrocytes  from  both
pregnant women  and cord blood  of  infants  at delivery are  inversely correlated  with  the  cor-
responding blood  lead  values,  using the activated/inhibited activity  ratio  method  of Granick
et al.  (1973).   The correlation coefficient  of  activity with lead level was higher  in  fetal
erythrocytes   (r =  -0.58, p <0.01) than  in the mothers  (r  = -0.43, p  <0.01).   The  mean  inhi-
bition level   was  28 percent in mothers  versus 12 percent in the newborn.   A study by Lauwerys
et al.  (1978) in  100  pairs of pregnant women  and  infant cord  blood samples  confirms  this
observation,   i.e., for  fetal   blood  r  = 0.67  (p <0.001)   and  for maternal  blood  r =  -0.56
(p <0.001).
     While several  factors  other  than lead may affect the  activity of erythrocyte ALA-D,  much
of the available  information suggests that most of these factors  do not materially compromise
the  interpretation of  the  relationship  between  enzyme activity  and  lead or the use  of  this
relationship  for screening purposes.  Border et al. (1976)  questioned the reliability of  ALA-D
activity  measurement   in  subjects  concurrently  exposed to  lead  and  zinc because  zinc  also
affects the  activity  of the enzyme.  The data of Meredith  and Moore (1980) refute this objec-
tion.  In unexposed subjects  who had serum  zinc  values  of 80-120 uM,  there  was only a  minor
activating effect with  increasing  zinc  when  contrasted  to the  correlation of  activity  and
blood  lead  in these  same  subjects.  In  workers exposed  to  both  lead and zinc,  serum  zinc
values were greater than in subjects with just lead exposure,  but  the mean level of enzyme ac-
tivity was still much  lower than in controls (p <0.001).
     The preceding discussion  indicates  that neither variability within  the  normal  range of
physiological zinc  in  humans  nor combined excessive zinc and lead exposure in workers materi-
ally affects   ALA-D activity.  The obverse of this, lead exposure in the presence of zinc  defi-
ciency, is probably a  more significant  issue, but one  that has not been well studied.   Since
ALA-D is a zinc-requiring  enzyme, one would expect that optimal activity would be governed by
j_n vivo  zinc availability.  Thus,  zinc  deficiency could potentially  have  a dual deleterious
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effect on  ALA-D activity:   first, a  direct  reduction in ALA-D activity through  reduced  zinc
availability,  and  second,  an  indirect and  further  inhibition of  ALA-D  activity because  of
enhanced lead  absorption in the presence  of zinc deficiency (see  Chapter 10,  Section  10.5).
     The recent study  of Roth  and Kirchgessner (1981) indicates that ALA-D activity  is  signi-
ficantly decreased in the presence of zinc deficiency.  In zinc-deficient rats showing reduced
serum and  urinary zinc  levels,  the  level of erythrocyte ALA-D activity was only 50 percent
that of pair-fed  controls,  while urinary ALA was  significantly elevated.   Although  these in-
vestigators did not measure blood lead in deficient and control animal groups, it would appear
that the level  of inhibition is more than can be accounted for just on the basis of  increased
lead absorption from the diet.   Given the available information documenting zinc deficiency in
children (Section 10.5) as well as the animal study of Roth and Kirchgessner (1981),  the rela-
tionship of  lead,  zinc deficiency,  and ALA-D activity in young children merits further, care-
ful study.
     Moore and  Meredith  (1979) noted the effects of carbon monoxide on the activity  of ALA-D,
comparing moderate or  heavy smokers with nonsmokers.   At the highest level of carboxyhemoglo-
bin measured in their  smoker  groups, the  depression of ALA-D activity was  2.1 percent.   In
these subjects,  a significant  inverse correlation of ALA-D activity  and  blood lead existed,
but there  was  no  significant correlation of  such activity and  blood carboxyhemoglobin levels.
     While  blood   ethanol  has   been  reported to  affect ALA-D  activity  (Moore et al.,  1971;
Abdulla et al., 1976), its effect is significant only under conditions of acute alcohol intox-
ication.   Hence,   relevance of  this  observation to  screening  is limited,  particularly  in
children.  The effect  is reversible, declining with clearing of alcohol from the blood stream.
     Lead-induced  inhibition of ALA-D activity in erythrocytes apparently reflects  a similar
effect in other tissues.  Secchi et al. (1974) observed a clear correlation in 26 lead workers
between  hepatic and erythrocyte  ALA-D activity  as  well as  the expected  inverse correlation
between  such activity  and blood lead  in  the range of 12-56 ug/dl.   In  suckling rats, Millar
et  al.  (1970)  noted decreased enzyme  activity in brain and liver as well  as erythrocytes when
lead was administered  orally.   In the study of Roels et  al. (1977), tissue ALA-D changes were
not observed when dams were administered  1, 10,  or 100  ppm lead in drinking water.   However,
the data of  Roels et  al.  (1977)  may reflect a lower effective dose taken in by the dams and
delivered  to the  rat pups  in  maternal milk,  because  the  pups  showed no tissue enzyme activity
changes.   Silbergeld et  al.  (1982)  described moderate  inhibition  of  ALA-D  activity in brain
and significant inhibition in kidney, liver,  and spleen when  adult  rats  were  acutely exposed
to  lead given intraperitoneally;  chronic exposure  was  associated with  reduced activity in
kidney,  liver,  and spleen.  Gerber et  al.  (1978)  found  that neonatal mice  exposed to  lead from
birth through  17  days of age  at a level  of  1.0 mg/ml in  water  showed  significant decreases in
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brain ALA-D  activity  (p <0.01) at all time points studied.   These results support the data of
Millar et  al.  (1970)  for the  suckling  rat.   In  the study by Millar et al.,  rats exposed from
birth through adulthood only showed significant decreases of brain ALA-D activity at 15 and 30
days;  this  finding  also supports  other data for  the developing  rodent.   It  would  appear,
therefore, that  brain  ALA-D activity is more  sensitive  to  lead in the developing animal  than
in the adult.
     The  study  of Dieter and  Finley  (1979)  sheds light on the relative  sensitivity  of ALA-D
activity  in  several  regions of the  brain  and permits  comparison of blood versus  brain ALA-D
activity as  a  function of lead level.   Mallard  ducks  given a single pellet of  lead  showed 1
ppm  lead  in  blood,  2.5 ppm lead  in  liver,  and 0.5 ppm lead  in  brain  by 4 weeks.   Cerebellar
ALA-D  activity  was  reduced by 50 percent at a  lead level  below 0.5  ppm; erythrocyte enzyme
activity was lowered by 75 percent.   Hepatic ALA-D activity was comparable to cerebellar acti-
vity or somewhat  less,  although the lead  level  in  the liver was fivefold higher.   Cerebellar
ALA-D activity was significantly below that for cerebrum.   In an avian  species,  then,  at blood
lead levels  at  which  erythrocyte  ALA-D activity  was significantly  depressed,  activity of the
enzyme in cerebellum was even  more affected relative to lead concentration.
     The inhibition of  ALA-D  is reflected by increased levels of its substrate,  ALA,  in urine
(Haeger, 1957)  as well  as in  whole blood or plasma (O'Flaherty et al., 1980; Meredith et al.,
1978; MacGee et  al. ,  1977;  Chisolm, 1968; Haeger-Aronsen, 1960).   Cramer et  al.  (1974) demon-
strated that ALA  clearance  into urine parallels  glomerular  filtration  rate  across a  range of
lead exposures,  suggesting  that  increased  urinary  output with increasing circulating ALA is
associated with decreased tubular reabsorption (Moore  et al., 1980).  Based  on  their  measure-
ments of  plasma and  urinary  ALA across  a range of blood  lead in  adults,  O'Flaherty et al.
(1980) calculated a mean fractional  reabsorption of  40  percent for ALA.   Tubular secretion
also occurs.   Reabsorption appears to be saturable.   In rats, fractional reabsorption  was much
higher, 90-99 percent.
     The detailed study of Meredith et  al.  (1978),  which involved  both  control  subjects and
lead workers, indicated that in elevated lead exposure  the increase in  urinary ALA is  preceded
by a significant rise in circulating levels of ALA.   The overall  relationship of plasma ALA to
blood lead was exponential and showed a perceptible continuity of the correlation even down to
the lowest blood lead value of the control group, 18 pg/dl.   The relationship of plasma ALA to
urinary levels  of the  precursor  was found  to be exponential, indicating that  as  plasma ALA
increases, a greater proportion of ALA undergoes  excretion into urine.   Inspection of  the plot
of urinary versus plasma ALA in these subjects shows that the correlation persists down to the
plasma  ALA concentration  corresponding to  the   lowest  blood  lead level,  18 ug/dl.    These
results are  contradicted by those of O'Flaherty  et  al.  (1980), who showed  no  correlation of
blood  lead  with plasma  ALA below a value of 40  ug/dl.   A key factor  in these  contradictory
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studies is the method  of ALA measurement.  Meredith et  al.  derived their data from a  colori-
metric technique that  measures  ALA as well  as other aminoketones,  while such aminoketones  are
not detected  in  the  gas-liquid  chromatography method used by  0'Flaherty  et al.   Although  the
measurements  of  0'Flaherty  et  al. are  generally  more  specific  for ALA  in plasma than  any
colorimetric technique,  their validity  at low plasma ALA  levels  remains  to be established in
the field  (see  Chapter  9).   The blood  (plasma) ALA values  reported by Meredith et al. were
generally higher than  those  measured  by 0'Flaherty et  al.  and appeared to be high in terms of
ALA renal  clearance  rates.   ALA is,  however  the  only  aminoketone studied so  far that corre-
lates  with  lead  directly.   Aminoacetone, also measured  in  the Meredith  et  al. study, is a
metabolite of an  ami no acid and is not known to be affected by lead exposure.   Thus, notwith-
standing a positive  bias in absolute ALA values,  the  relative changes in ALA would appear to
provide the most plausible basis for the  observed correlation with blood lead levels as low as
18 ug/dl in the study by Meredith et al.
     Urinary  ALA  has  been  employed extensively as  an  indicator  of excessive lead exposure,
particularly  in  occupational settings  (e.g.,  Davis  et al.,  1968;  Selander  and Cramer, 1970;
Alessio  et  al.,  1976a).   The  reliability  of this test in  initial  screening  of children  for
lead  exposure has been  questioned by  Specter  et  al.  (1971) and  Blanksma  et  al.  (1969),  who
pointed  out  the failure of urinary  ALA analysis  to detect lead  exposure  when compared with
blood  lead  values.   This is due to the  fact that an individual subject will show a wide vari-
ation  in  urinary  ALA with random  sampling.   Chisolm et al.  (1976) showed that reliable levels
could  only be  obtained  with  24-hr  collections.   In  children  with blood  lead levels above
40 ug/dl, the relationship of  ALA  in  urine  to  blood lead becomes similar to  that observed in
lead workers  (see below).
     A  correlation  exists  between blood lead and  the logarithm  of urinary  ALA  in  workers
(Meredith  et al.,  1978;  Alessio   et  al.,   1976a;  Roels  et al.,  1975a;  Wada  et  al., 1973;
Selander and  Cramer, 1970) and  in  children  (National Academy of Sciences, 1972).  Selander  and
Cramer (1970) reported that two different  correlation  curves  were  obtained,  one for  individ-
uals  below  40 ug/dl  blood lead and a different one for  values above this, although the degree
of correlation was less than with the  entire group.   A similar observation has been  reported
by Lauwerys  et  al. (1974) from  a  study  of 167 workers  with blood lead levels  of 10-75 ug/dl.
     Meredith et  al.  (1978) found  that  the  correlation  curve  for  blood ALA  versus  urinary  ALA
was linear below a blood lead of 40 Mfl/dl,  as was  the  relationship of blood  ALA  to  blood lead.
Hence,  there  was also  a  linear  relationship  between blood  lead and urinary  ALA below 40 ug/dl,
i.e.,  a continuation of  the  correlation  below the  commonly accepted threshold  blood lead value
of 40  ug/dl  (see below).   Tsuchiya et al. (1978) have  questioned  the relevance of using  single
correlation curves to  describe  the blood lead-urinary  ALA  relationship across  a broad  range of
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exposure, because they found that this relationship in workers showing moderate,  intermediate,
and high  lead  exposure could be described by  three  correlation curves with different slopes.
This  finding is  consistent with the observations of Selander and Cramer (1970) as well  as the
results of Meredith et al. (1978) and Lauwerys et al.  (1974).  Chisolm et al.  (1976) described
an  exponential   correlation  between blood lead  and  urinary  ALA  in children  5  years  old  or
younger, with  blood  lead levels ranging from 25 to 75 (jg/dl.  The upward slope in the regres-
sion  line  appears to  be most  pronounced  at a  blood  lead  level  of about 40 ug/dl,  but the
correlation may  persist  below this level.    In adolescents  with blood  lead below 40 ug/dl,  no
clear correlation was observed.
      It  is  apparent from  the above  reports (Tsuchiya et  al. ,  1978;  Meredith  et  al.,  1978;
Selander and Cramer, 1970) that circulating ALA and urinary ALA levels  are elevated and corre-
lated at blood  lead  values below 40 ug/dl  in humans.   These findings are consistent,  as shown
in the Meredith et al.  (1978) study, with the significant and steady increase  in  ALA-0 inhibi-
tion concomitant with rising blood levels of  ALA, even at blood lead values considerably below
40 ug/dl.  Increases of  ALA in tissues of experimental animals exposed to lead have also been
documented.   In  the study of  Silbergeld  et al.  (1982),  acute administration  of  lead  at  a
rather high dose  to  adult rats was associated with an elevation in spleen and kidney ALA com-
pared to that  of controls, while in chronic exposure  there was a moderate increase in ALA  in
the brain and  a  large  increase (9-fold  to 15-fold)  in kidney and spleen.  Liver  levels with
either form of exposure  were not materially affected, although  there  was inhibition of liver
ALA-D, particularly in  the acute dose group.
12.3.1.3  Effects of Lead  on Heme Formation  from Protoporphyrin.   The  accumulation of  proto-
porphyrin in the  erythrocytes  of individuals with lead intoxication has  been  recognized since
the 1930s (Van  den Bergh and Grotepass, 1933),  but it has only recently been possible to study
this effect through  the  development of sensitive and specific analytical techniques that per-
mit quantitative  measurement.   In  particular,  the development of  laboratory  microtechniques
and the hematofluorometer  has  allowed the determination of  dose-effect  relationships as well
as the use of such measurements to screen for lead exposure.
     In  humans  under  normal  circumstances,  about 95  percent of  the  protoporphyrin in  cir-
culating erythrocytes  is zinc  protoporphyrin  (ZPP), with  the remaining 5  percent  present  as
"free" protoporphyrin  (Chisolm  and  Brown,  1979).   Accumulation  of  protoporphyrin IX  in the
erythrocytes  is  the  result  of  impaired iron  (II) placement in the porphyrin moiety to form
heme,  an intramitochondrial  process.   In lead exposure,  the porphyrin acquires  a zinc  ion  in
lieu of the native  iron; the resulting ZPP is  tightly bound in the available  heme pockets for
the life of the  erythrocyte,  about 120  days (Lamola  et  al., 1975a,b).   Hammond  and coworkers
(1985) recently  observed that  in  a group of  young children  aged 3-36 months  (n  =  165) the
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fraction of ZPP versus total erythrocyte protoporphyrin (EP) varied with age;  it was  at a  min-
imum at 3 months and approached unity at 33 months.   The basis for the age-related instability
of this  ratio  may  be either a biological  factor  or an artifact of analytical  methodology.   A
plausible biological  basis  is  that zinc bioavailability and zinc nutritional  status  (subopti-
mal in the  early  age groups) determine the  extent  of zinc placement in EP.   The significance
of these observations for  EP  screening of  very  young children has been noted  in Chapter  9.
     In  lead poisoning, the accumulation of protoporphyrin differs from that seen in  the gene-
tically  transmitted disorder erythropoietic  protoporphyria.   In the latter case, there  is  a
defect  in  ferrochelatase  function,  i.e.,  enzyme  function is  only  10-25  percent  of normal
(Bloomer, 1980),  leading  to loose attachment of  the  porphyrin,  accumulated without uptake of
zinc,  on the surface of  the  hemoglobin.   Loose attachment permits diffusion  into plasma and
ultimately  into the  skin, where photosensitivity  is induced.   This  behavior  is  absent  in
lead-associated porphyrin accumulation.  The two forms of porphyrin, free and zinc-containing,
differ  sufficiently in fluorescence  spectra to  permit a  laboratory  distinction.   With  iron
deficiency,  there  is  also  accumulation  of  protoporphyrin  as the zinc  complex in  the  heme
pocket;  this resembles in large measure the characteristics of lead intoxication.
     The elevation  of erythrocyte ZPP has been extensively documented as exponentially corre-
lated with  blood lead in  children (Piomelli  et  al., 1973; Kammholz et al., 1972;  Sassa et al.,
1973;  Lamola et al.,  1975a,b; Roels  et  al.,  1976)  and in  adult workers  (Valentine et  al.,
1982;  Lilis et al., 1978;  Grandjean  and  Lintrup, 1978; Alessio et al.,  1976b; Roels et  al.,
1975a, 1979; Lamola et al., 1975a,b).   Reigart and Graber (1976) and  Levi et  al. (1976) have
demonstrated that  ZPP elevation  can predict which  children tend to  increase their blood lead
levels,  a circumstance that probably  rests  on  the  nature of  chronic lead exposure  in certain
groups  of young children where a pulsatile  blood lead curve  is superimposed on  some  level of
ongoing  intake  of  lead that continues  to elevate  the  ZPP  values.
     Accumulation  of  ZPP  only  occurs  in erythrocytes  formed during lead's presence in  erythro-
poietic  tissue.   This results in a lag of several  weeks  before the  fraction of new  ZPP-rich
cells  is large enough to  influence total  cell  ZPP level.   On the other  hand,  elevated ZPP  in
erythrocytes  long after significant  lead  exposure  has ceased appears to  be a better indicator
of resorption  of  stored  lead  in bone  than  other measurements.   Alessio  et al.  (1976b)  reported
that former lead workers  removed  from exposure  at the workplace for more  than  12 months in all
cases  still showed the typical logarithmic  correlation between ZPP and blood  or urinary  lead.
However, the best  correlation was observed between ZPP  and  chelatable  lead,  that fraction  of
the  total body burden considered toxicologically active (see Chapter 10).  This post-exposure
relationship for  adults  clearly   indicates  that  significant  levels  of hematologically  toxic
lead continue  to  circulate long after exposure  to lead has ceased.
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     In a  report  relevant  to the problem of multiple-indicator measurements  in the  assessment
of the degree  of  lead exposure, Hesley and Wimbish  (1981)  studied changes in blood  lead  and
ZPP  in  two groups:  newly exposed  lead  workers  and those removed  from  significant exposure.
In new workers, blood  lead achieved a plateau at 9-10 weeks,  while ZPP continued to rise over
the entire  study  interval  of 24 weeks.  Among workers  removed from exposure,  both  blood lead
and  ZPP  values  remained elevated  up  to the  end of this  study period  (33  weeks), but  the
decline in ZPP concentration lagged behind blood  lead in reaching a plateau.   These  investiga-
tors logically  concluded that  the  difficulty in demonstrating reliable blood  lead-ZPP rela-
tionships  may  reflect  differences  in the time at which the two measures  reach  plateau.   The
authors also suggested that more reliance should  therefore be  placed on ZPP than on  blood lead
levels before permitting re-entry into areas of elevated lead  exposure.
     The threshold  for the  effect  of lead  on ZPP  accumulation  is affected  by  the relative
spread of  blood lead  values  and the corresponding concentrations of ZPP.   In many cases these
range from  "normal" levels  in nonexposed subjects to values reflecting considerable exposure.
Furthermore, iron deficiency  is  also associated  with ZPP elevation, particularly in children
2-3 years old or younger.
     For EP  elevation in  adults,  Roels  et  al.   (1975b)  found that the  relationship of this
effect to  blood  lead  ended at 25-30 ug/dl,  confirmed by the  log-transformed  data  of Joselow
and Flores  (1977),  Grandjean  and Lintrup (1978), Odone  et  al.  (1979), and Herber (1980).   In
children 10-15 years  of  age,  the data of Roels  et al.  (1976) indicate an effect threshold of
15.5 ug/dl.   In  this  study  the threshold was taken  as  the  point of intersection  of two  re-
gression lines derived from two groups of children.   The population dose-response relationship
between EP and blood lead in these children indicated that EP  levels were significantly  higher
(>2 standard deviations) than the reference mean  in 50 percent of the children at a  blood lead
level of 25 ug/dl.  In the age range of children  studied here, iron deficiency is uncommon  and
these investigators did  not  note any significant hematocrit change in  the exposure  group.   In
fact, hematocrit was lower in the control group,  although these subjects had lower ZPP levels.
In this  study, then,  iron deficiency was  unlikely  to  have been a confounding  factor  in  the
primary  relationship.    Piomelli  et al.   (1977)  obtained a comparable threshold value  (15.5
ug/dl) for  lead's  effect on ZPP elevation  in  children  who  were older  than 4 years  as well as
those who  were 2-4 years old.   If  iron  deficiency  was  a factor in the results for  this  large
study population  (1816  children),  one would  expect  a  greater  impact  in the  younger  group,
where the deficiency is more common.
     Within the blood  lead range considered "normal,"  i.e.,  below 30-40 (jg/dl, assessment of
any ZPP-blood  lead  relationship is strongly influenced by the relative analytical proficiency
of the laboratory carrying out both measurements, particularly for blood lead at lower values.

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The type of statistical  treatment of the data is also a factor,  as are some biological  sources
of variability.   With respect to subject variability, Grandjean (1979) has documented that ZPP
increases  throughout adulthood,  while hemoglobin  remains  relatively  constant.  Hence,  age
matching is a prerequisite.   Similarly, the relative degree of ZPP response depends on gender:
females  show  a  greater  response for a given  blood lead level  than  do males  (see discussion
below).
     Suga  et  al.  (1981)  claimed no  apparent correlation between   blood  lead   levels  below
40 ug/dl and  blood  ZPP  content in an adult  population of 395 male and female subjects.   The
values for males and females were combined because of no measured differences in ZPP response,
which  is at  odds with  the  studies  of Stuik  (1974),  Roels  et  al.   (1975b),  Zielhuis et al.
(1978a,b), Odone et al.  (1979), and Toriumi and Kawai (1981).  Also,  EP was found to increase
with  increasing  age, despite the fact  that  the finding of no correlation  between blood lead
and ZPP  was based on a study population with all age groups combined.
     Piomelli et al.  (1982) investigated both  the  threshold for the  effect of lead on EP ac-
cumulation  and  a dose-response  relationship  in  2004  children,   1852 of  whom had blood lead
values  below  30  pg/dl.   In this study, blood  lead and EP measurements were done in facilities
with  a high proficiency for both blood lead and ZPP analyses.  The study employed two statis-
tical  approaches  (segmental  line  techniques and probit analysis), both  of which revealed an
average  threshold blood lead level of  16.5  ug/dl  in the full group  and  in the children with
blood  lead values  below 30 ug/dl.   In this report, the effect  of iron  deficiency and other
non-lead factors was tested and  removed using  the Abbott formula  (Abbott, 1925).  With respect
to  population dose-response  relationships,  it was  found that blood lead  values of 28.6 and
SS.^MQ/d1  corresponded to  significant EP elevation of  more than 1  or 2 standard deviations,
respectively, above a reference mean  in 50  percent  of the subjects.  At  a  blood  lead  level of
30  ug/dl,  furthermore,  it  was  determined that 27 percent of  children would have  an  EP greater
than  53 ug/dl.
      In a related  study  (Rabinowitz  et al., 1986), simultaneous blood lead,  ZPP, and hemato-
crit  measurements were  made semi annually on  232 normal  infants during their first two  years of
life.   The incidence of elevated ZPP  (mean + 1 or 2 S.D.) was unrelated to  blood lead  below 15
Mg/dl  but was 4-fold greater  above  this  threshold.  The relationship persisted after correc-
tion  for  the small number (4 percent) of  infants with  a  hematocrit below 33 percent.   This
survey extends  the  observations of  Piomelli et al.  (1982) to a  younger and less lead-burdened
population.
      Comparison  of  EP elevations among adult  males and females  and  children  at a given blood
lead  level generally indicates  that  children  and adult females  are more  sensitive to this ef-
fect  of lead.  Lamola  et al.  (1975a,b) demonstrated that the  slope  of ZPP versus  blood  lead

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was  steeper in children  than in adults.   Reels  et  al.  (1976) found that women  and children
were equally more sensitive in response than adult males, a finding also observed in the popu-
lation  studied by Odone  et al.   (1979).   Other comparisons between adults,  either  as  groups
studied  at random or  in a voluntary  lead exposure  study,  also document the  sensitivity of
females  over  males to  this effect  of  lead (Stuik,  1974;  Roels et  al.,  1975b, 1976,  1979;
Toriumi  and Kawai,  1981).   The heightened response of females to lead-associated EP elevation
has  also  been  investigated  in rats  (Roels  et  al.,  1978a)  and has been shown to be  related to
hormonal  interactions with  lead,  thus confirming the human data of Roels et al.  (1975b, 1976,
1979) that  iron status is not a factor in the phenomenon.
     The  effect  of lead  on iron incorporation  into protoporphyrin in  the  heme  biosynthetic
pathway  is  not restricted to  the erythropoietic  system.   Evidence  of  a generalized effect of
lead on  tissue heme  synthesis at low levels of lead exposure comes from the recent  studies of
Rosen  and coworkers  (Rosen et al.,  1980,  1981;  Mahaffey et al.,  1982)  concerning  lead-asso-
ciated  reductions  in 1,25-dihydroxyvitamin D (1,25-(OH)2D)  (see Section 12.3.5).   Such  re-
ductions  probably occur  because  lead has an inhibitory effect on renal  1-hydroxylase,  a heme-
requiring  cytochrome  P-450 mediated mitochondrial  enzyme  system  that converts  25-hydroxy-
vitamin D to 1,25-(OH)2D.   In  an independent study,  it  has  been shown in  animals chronically
exposed  to moderate amounts  of  lead that  kidney ferrochelatase  activity  is  inhibited  with
elevation  of  EP,  reducing  the kidney  heme pool  for  heme-requiring  enzymes (Fowler  etal.,
1980).    The low end of  the blood  lead range  associated with lowered 1,25-(OH)2D  levels  and
inhibited 1-hydroxylase activity corresponds to the level of lead associated with the onset of
EP  accumulation  in  erythropoietic   tissue  (see  above).   Sensitivity  of renal  mitochondrial
1-hydroxylase  activity  to lead  is  consistent with  a large body  of  information showing  the
susceptibility of renal  tubule cell mitochondria to  injury  by  lead and with the chronic lead
exposure animal model  of Fowler et al.  (1980),  discussed in more detail  below.
     Formation of the heme-containing protein  cytochrome P-450, which  is an integral  part of
the  hepatic mixed-function  oxygenase system,  has been documented  in  animals (Alvares  et al.,
1972; Scoppa et al.,  1973;  Chow and Cornish, 1978;  Goldberg et al., 1978;  Meredith  and Moore,
1979) and humans (Alvares et al., 1975;  Meredith et al. ,  1977;  Fischbein et al., 1977;  Saenger
et al.,  1984)  as  being  affected by lead exposure, particularly acute  lead  intoxication.   Many
of  these studies  used   altered  drug detoxification  rates  as  a  functional  measure of  such
effects.  In the work of Goldberg et al. (1978),  increasing the level  of lead exposure  in rats
was  correlated with both a  steadily decreasing P-450 content of hepatic microsomes  and decre-
ased activity  of  the  detoxifying  enzymes aniline  hydroxylase  and aminopyrine  demethylase.
Similarly,  the  data  of  Meredith  and Moore  (1979)  showed  that continued dosing of  rats  with
lead results in steadily decreased  microsomal  P-450  content, decreased  total heme  content of
microsomes, and increased ALA-S activity.
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     Recently, Saenger and coworkers  (1984)  demonstrated that there was  significantly  reduced
6B-hydroxylation  of  cortisol  in  children having  a  positive  ethylenediaminetetraacetic  acid
(EDTA) provocation  test  compared to a  negative  test group, under conditions of  age matching
and  controlling  for  free  cortisol.    Because  6B-hydroxycortisol  formation  is  mediated  by
hepatic  cytochrome  P-450  microsomal  monooxygenase,   lead  appears to  inhibit  this system  at
relatively moderate levels of lead exposure in children.
     According  to  Litman and  Correia  (1983),  treatment  of  rats  with  either  the  organic
porphyrinic  agent  3,5-dicarbethoxy-2,6-dimethyl-4-ethyl-l,4-dihydropyridine  (DDEP)   or  in-
organic  lead  is  associated  with  an  inhibition  of the  hepatic  enzyme  system  tryptophan
pyrrolase,  owing  to depletion  of the  hepatic  heme  pool and  resulting  in  elevated  levels  of
tryptophan,  serotonin,  and 5-hydroxyindoleacetic  acid in the brain.  With  infusion of heme,
however,  brain  levels  were  restored  to  normal.    These  studies  were  carried  out  with
phenobarbital   induction   of   the  enzyme  system.   The  behavior  of  lead  alone  was  not
investigated.
     Of  interest  in this  regard  are  data relating to neural  tissue.   Studies  of organotypic
chick  dorsal  root ganglion in culture  document  that the nervous system has heme biosynthetic
capability  (Whetsell  et  al.,  1978) and  that  this  cell system elaborates decreased amounts of
porphyrinic  material  in  the  presence of lead (Sassa  et  al., 1979).  In a  later investigation,
Whetsell  and coworkers  (Whetsell  and Kappas, 1981; Whetsell et al., 1984) reported that mouse
dorsal  root ganglion in  culture exposed  to  lead for 6 weeks at 10"   M  (2 ug Pb/ml  medium)
showed  progressive  severe destruction  of  myelin and Schwann  cells  as well  as alterations in
axonal  and  neuronal  ultrastructure.   Because the  co-administration  of heme  (10   M) prevented
most  of  these destructive  effects, particularly  in Schwann  cells, axons, and neurons,  there is
an  indication of  a relationship between  inhibition by lead  of  heme biosynthesis in neural tis-
sue and  the  morphological  changes observed.
      Chronic administration of  lead to  neonatal  rats  indicates that  at low levels  of exposure,
with  modest elevations  of blood lead,  there is  a   retarded  growth in the respiratory  chain
hemoprotein  cytochrome C  and  disturbed  electron  transport  function  in  the  developing rat  cere-
bral  cortex  (Bull et  al. ,  1979).  The study of Holtzman  et  al.  (1981)  indicates that the  cyto-
chrome  group affected and the brain region affected  appear  to  differ with  the  age  of the  young
animal   at  the  start of  dosing  and  the  duration of dosing.   All  measured changes  involved
reduction at the p <0.05  level.   Young rats fed  lead from birth for  3  weeks  showed reduction
in  cytochrome aa3 of cerebral  mitochondria,  while feeding  for 4  weeks showed  reduction  in  all
cerebellar  mitochondrial  cytochromes.   When  feeding  commenced  at  2  weeks,  the  range of effects
also  depended on  duration of  exposure,  with  reduction of cytochrome b  in cerebral  mitochondria
after one week,  reduction in  cytochrome c  + ^  in  cerebral  mitochondria  after 2 weeks,  and
cerebellar   cytochrome  c  +  Cj  reduction  after two  weeks.  These  effects  on the  developing
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organism  are accentuated  by  increased  whole body lead retention  in  both  developing children
and experimental  animals  as well as by higher retention of lead in the brain of suckling rats
as compared  to adults.
     Heme oxygenase activity is elevated in lead-intoxicated animals (Maines and Kappas, 1976;
Meredith  and Moore, 1979)  in  which  relatively high dosing is  employed.   This  indicates that
normal  repression  of  the  enzyme's activity is lost, further adding to heme reduction and loss
of regulatory control on the heme biosynthetic pathway.
     The mechanism(s)  underlying  derangement of heme biosynthesis leading to ZPP accumulation
in lead intoxication  can  be ascribed to impaired mitochondrial transport of iron, ferrochela-
tase inhibition,  or a combination of both.   Lead-induced  effects  on  mitochondrial morphology
and function, which are well known (Goyer and Rhyne, 1973; Fowler,  1978), may include impaired
iron transport (Borova  et  al.,  1973).   Moreover, the resemblance of lead-associated ZPP accu-
mulation to  a  similar effect of iron deficiency is consistent with the unavailability of iron
to ferrochelatase  rather than  with direct enzyme  inhibition.   However,  the porphyrin pattern
seen in  the  congenital  disorder erythropoietic porphyria, where ferrochelatase  itself is af-
fected, is different from that seen in lead intoxication.
     Several  animal  studies indicate that the  effects  of lead on heme  formation  may involve
both ferrochelatase inhibition  and  impaired  mitochondrial  transport of  iron.   Hart  et al.
(1980)   observed  that  acute lead  exposure in  rabbits  is associated  with a two-stage hema-
topoietic response:   an earlier  phase  that  results  in significant formation of  free versus
zinc protoporphyrin with considerable  hemolysis and a  later  phase (where  ZPP is formed) that
otherwise resembles the common features of lead intoxication.   Subacute exposure shows more of
the typical  porphyrin response  reported  with  lead.   These  data may  suggest that  acute lead
poisoning is quite different  from chronic exposure  in terms of  the  nature  of  hematological
derangement.
     Fowler et al. (1980)  maintained  rats on a regimen of oral lead,  starting with exposure of
their  dams   to  lead in water  and continuing  through  9 months  after birth  at  levels  up  to
250 ppm lead.  The authors  observed that the activity of kidney mitochondrial  ALA-S and ferro-
chelatase, but not that of the cytosolic enzyme ALA-D,  was inhibited.   Ferrochelatase activity
was inhibited at 25-,  50-,  and 250-ppm exposure levels; activity was  63 percent  of the control
values   at  the 250-ppm  level.   Depression  of state-3 respiration  control  ratios  was observed
for both succinate  and  pyruvate.   Ultrastructurally, the mitochondria were  swollen and lyso-
somes  were   rich  in  iron.   In this study,  reduced ferrochelatase activity  was  observed  in
association  with mitochondrial  injury  and  disturbance of function.  The  accumulation of iron
may have been  the result  of phagocytized dead  mitochondria  or it may have represented intra-
cellular accumulation  of  iron,  owing  to the  inability of mitochondria  to use  the element.
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Ibrahim et al.  (1979) have shown that excess intracellular iron under conditions  of  iron over-
load is stored  in  cytoplasmic lysosomes.   The observation of disturbed  mitochondria!  respira-
tion suggests,  as  do the mitochondria!  function data of Holtzman and Shen Hsu  (1976)  and Bull
et  a!.  (1979)   for  the  developing nervous  system,  that intramitochondrial transport of iron
would be impaired.  Flatmark and Romslo (1975) demonstrated that iron transport  in mitochondria
is  energy  linked and requires  an intact respiration chain  at the level of cytochrome C,  by
which  iron  (III) on  the C-side of  the mitochondrial  inner  membrane is reduced  before it  is
transported to the M-side and utilized in heme formation.
     The above results are particularly interesting in terms  of the relative responses of dif-
ferent tissues.  While  the kidney was affected, there was no change in  blood indices  of  hema-
tological  derangement  in  terms  of  inhibited  ALA-D activity or  accumulation of  ZPP.  This
suggests that there  is a difference  in dose-effect functions  among different tissues,  particu-
larly  with  lead exposure  during development  of  the organism.   It appears that while  blood
indicators of  erythropoietic  effects of lead may be more accessible, they may not be  the most
sensitive indicators of  heme biosynthesis derangement in other organs.
12.3.1.4  Effects  of Lead  on  Coproporphyrin.   An  increased excretion of coproporphyrin in  the
urine  of  lead  workers and children  with  lead poisoning has  long been recognized, and urinary
coproporphyrin  measurement has  been used as  an indicator of lead poisoning.  The mechanism of
this  enhanced  production  of  coproporphyrin may be  direct enzyme  inhibition,  accumulation of
substrate  secondary to  inhibition of heme  formation,  or impaired intramitochondrial  movement
of  the coproporphyrin.    Excess coproporphyrin excretion  differs  from  EP  accumulation  as an
indicator  of  lead exposure.   The former is  a measure of ongoing lead intoxication without the
lag in response seen with  EP  (Piomelli and Graziano, 1980).
      In experimental  lead  intoxication, there is an  accumulation of porphobilinogen and eleva-
ted excretion   in  urine,  owing  to inhibition by lead  of the enzyme uroporphyrinogen (URO)-I-
synthetase  (Piper and Tephly,  1974).   In  vitro studies of  Piper  and Tephly (1974) using  rat
and human  erythrocyte   and  liver preparations  indicate  that it  is  the  erythrocyte enzyme
URO-I-synthetase in both rats  and humans  that is  sensitive to the inhibitory effect of lead;
activity  of  the  hepatic  enzyme is relatively  insensitive.   Significant  inhibition  of  the
enzyme's  activity  occurs  at  5  uM  lead and  virtually  total  inhibition of activity occurs in
human erythrocyte  hemolysates  at 10"   M.   According to Piper and van  Lier (1977), the lower
sensitivity  of hepatic  URO-I-synthetase  activity to  lead  is  due to a  protective effect
afforded  by a  pteridine derivative,  pteroylpolyglutamate.  It appears that  the protection  does
not occur through  lead  chelation,  since  hepatic ALA-D  activity  was reduced in the  presence of
 lead.   The  studies  of Piper  and   Tephly  (1974)   indicate  that  it is  inhibition of URO-I-
 synthetase in erythroid tissue  or  erythrocytes that accounts for the accumulation  of its  sub-
 strate,  porphobilinogen.
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     Unlike the case  for  experimental  animals, accumulation of porphobilinogen  in  plasma and
urine of lead-exposed humans has not been conclusively documented.   Absence of porphobilinogen
in urine is  a differentiating characteristic in heme  biosynthesis  disturbance by lead versus
the  hepatic  porphyrias,  acute  intermittent  porphyrin, and  variegate porphyria (Eubanks  et
al., 1983).

12.3.2  Effects of Lead on Erythropoiesis and Erythrocyte Physiology
12.3.2.1   Effects of  Lead on  Hemoglobin  Production.   Anemia is a manifestation  (sometimes  an
early one) of chronic lead intoxication.   Typically, the anemia is  mildly hypochromic and usu-
ally normocytic.  It is associated with reticulocytosis, owing to shortened cell  survival, and
the irregular presence of basophilic stippling.  Its genesis lies in both decreased hemoglobin
production and an increased rate of erythrocyte destruction.  Not only is anemia commonly seen
in  children  with lead  poisoning,  but it appears  to  be more severe and  frequent among those
with severe  lead  intoxication (World Health Organization,  1977;  National Academy of Sciences,
1972; Lin-Fu, 1973;  Betts et al., 1973).
     While the  anemia associated with  lead intoxication in children  shows  features  of iron-
deficiency anemia, there  are  differences in cases  of  severe  intoxication.   These differences
include reticulocytosis,  basophilic stippling,  and a significantly lower  total  iron binding
capacity (TIBC).  These  latter features  suggest that iron-deficiency anemia in young children
is exacerbated by lead.  The reverse is also true.
     In young children,  iron  deficiency  occurs  at  a  significant rate,  based on  national
(Mahaffey and Michaelson, 1980) and regional (Owen and Lippman, 1977) surveys, and it is known
to  be  correlated  with increased lead absorption  in humans  (Yip  et  al.,  1981;  Chisolm, 1981;
Watson et  al. ,  1980;  Szold, 1974; Watson et al., 1958) and animals (Hamilton, 1978; Barton et
al., 1978;  Mahaffey-Six and  Goyer,  1972).   Hence,  prevalent iron deficiency can  be seen  to
potentiate the  effects  of lead in reduction of  hemoglobin  both  by increasing lead absorption
and by exacerbating the degree of anemia.  Also, in young children,  there is a negative corre-
lation between  hemoglobin level and blood  lead levels (Adebonojo,  1974; Rosen  et  al., 1974;
Betts et al., 1973;  Pueschel et al., 1972).   These studies  generally involved children under 6
years of age in whom iron deficiency may have been a factor.
     In adults,  a negative correlation  was  observed  in several  studies  at  blood lead values
usually below  80 pg/dl  (Grandjean,  1979;   Lilis  et al., 1978;  Roels et al., 1975a;  Wada  et
al., 1973), while several studies did not report any relationship below 80 ug/dl  (Valentine et
al., 1982;  Roels  et al., 1979;  Ramirez-Cervantes  et al.,  1978).   In  adults,  iron  deficiency
would be expected to  play less of a  role  in this  relationship;  Lilis  et al.  (1978) reported
that the  significant correlation between lead  in  blood and hemoglobin  level  was observed  in
workers in whom serum iron and TIBC were indistinguishable  from controls.
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     The blood  lead  threshold  for  effects  on  hemoglobin has  not  been conclusively estab-
lished.   In  children,  this value  appears to  be  about 40  ug/dl  (World Health  Organization,
1977), which is somewhat  lower  than in adults (Adebonojo,  1974;  Rosen  et  al., 1974;  Betts et
al., 1973;  Pueschel et  al.,  1972).  Tola et al.  (1973)  observed no effect of lead on new work-
ers until the blood  lead  had risen to  a  value of 50 (jg/dl after about  100 days.   The regres-
sion  analysis data of  Grandjean  (1979),   Lilis  et al.  (1978),  and  Wada  et  al.  (1973)  show
persistence  of  the negative correlation of  hemoglobin  and blood lead below 50  ug/dl-  Human
population dose-response data for  the lead-hemoglobin  relationship are  limited.   Baker et al.
(1979)  calculated  the  following percentages  of  lead  workers having  a hemoglobin  level of
<14.0 g/dl   blood   at  the  specified  blood  lead  concentrations:   5  percent at blood  lead
values of 40-59 ug/dl; 14 percent at blood lead values  of 60-79 ug/dl;  and  36 percent  at blood
lead  values  above  80 ug/dl.   In 202  lead workers, Grandjean (1979) noted  the following  per-
centages of  workers having  a  hemoglobin  level  below  14.4  g/dl  at the specified blood  lead
concentrations:   17  percent at  <25 pg/dl;  26 percent  at 25-60 pg/dl;  and 45 percent at >60
ug/dl.
     The underlying mechanisms of lead-associated anemia appear to be a combination of reduced
hemoglobin production and shortened erythrocyte survival because of direct cell  damage.  Under
hemoglobin production, biosynthesis of  globin, the protein moiety of hemoglobin,  appears to be
inhibited  as a result  of lead exposure  (Dresner  et al., 1982; Wada et al., 1972; White and
Harvey,  1972; Kassenaar et al., 1957).  In  the study of White and Harvey (1972), two children
treated  for  lead  intoxication were studied  for  reticulocyte incorporation of a labeled ami no
acid  into alpha  and  beta globin  chains over  a post-treatment  period when blood  lead was
declining.   These  workers observed that  a  lag  in de  novo  biosynthesis of alpha versus  beta
chains  diminished  toward  a normal  ratio  (1.0)  as blood lead  approached 20 ug/dl.  These data
are in  accord with the observation  of Dresner et al.   (1982), who noted a  reduced globin syn-
thesis  (76 percent of controls)  in  rat bone  marrow suspensions exposed  to  1.0 uM lead.
      Disturbance of  globin biosynthesis is  a  consequence of lead's effects on  heme  formation
because  cellular  heme  regulates  protein synthesis in erythroid cells (Levere and   Granick,
1967) and  regulates the translation of globin  messenger RNA, which may  also reflect the effect
of lead  on pyrimidine metabolism (Freedman and Rosman,  1976).
12.3.2.2  Effects  of  Lead  on  Erythrocyte  Morphology  and Survival.   It is clear that there  is a
hemolytic  component to lead-induced  anemia  in humans  owing to shortened erythrocyte  survival;
the various aspects  of this effect have been  reviewed  by Waldron  (1966), Goldberg  (1968),
Moore et al.  (1980),  Valentine  and Paglia (1980),  and  Angle and Mclntire (1982).
      The relevant  studies of shortened cell life with lead intoxication  include observations
of the  response of erythrocytes to mechanical and  osmotic  stress  under iji vivo  and  jri  vitro
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conditions.  Waldron (1966) has discussed the frequent reports of increased mechanical  fragil-
ity of  erythrocytes  from lead-poisoned workers, beginning with the observations of Aub et al.
(1926).  Increased osmotic  resistance  of erythrocytes from subjects with lead intoxication is
a  parallel  finding,  both  jui  vivo  (Aub and  Reznikoff,  1924;  Harris  and Greenberg,  1954;
Horiguchi  et  al.,  1974)  and jjn vitro  (Qazi  et  al.,  1972; Waldron, 1964;  Clarkson  and Kench,
1956).  Using an apparatus called a coil planet centrifuge, Karai et al.  (1981) studied eryth-
rocytes  of lead workers  and  found significant  increases in osmotic resistance; at the  same
time, mean  corpuscular volume  and reticulocyte counts were  not  different from controls.   The
authors  suggested  that one mechanism  of increased resistance involves  impairment  of  hepatic
lecithin-cholesterol  acyltransferase,  leading to  a  build-up of cholesterol in  the cell  mem-
brane.  This  resembles the  increased  osmotic resistance seen in obstructive jaundice  in which
increased membrane cholesterol  has  been observed (Cooper  et  al.,  1975).   Karai et al. (1981)
also  reported  an  increased  cholesterol-phospholipid  ratio  in  lead workers'  erythrocytes.
     Fukumoto and  coworkers (1983) studied  the electrophoretic profiles  of  erythrocyte  mem-
brane  proteins  of a group  of  lead workers  and  found  that compared to  controls there was a
significant negative correlation (r = -0.51,  p <0.01) between blood lead and a membrane trans-
fer protein associated with Na  and water transport.   It appears that one factor  in  reduced
erythrocyte membrane permeability with lead exposure is a decrease in this protein.
     Erythrokinetic  data  in lead workers  and children with  lead-associated anemia have  been
reported.  Shortening of erythrocyte survival has been demonstrated by Hernberg et al.  (1967a)
using tritium-labeled difluorophosphonate.   Berk et  al.  (1970)  used  detailed  isotope  studies
of a  subject  with  severe lead intoxication  to  determine shorter erythrocyte life span, while
Leikin  and Eng (1963) observed shortened cell  survival  in  three of seven  children.  These
studies, as well  as the reports of Landaw  et  al.  (1973), White  and Harvey  (1972),  Albahary
(1972), and Dagg et al.  (1965), indicate that hemolysis is not the exclusive mechanism of ane-
mia and that diminished erythrocyte production also plays a role.
     The molecular basis  for  increased cell  destruction with lead exposure includes the inhi-
bition  by  lead  of  the  activities of the enzymes  (Na ,  K )-ATPase and pyrimidine-5'-nucleoti-
dase (Py-5-N).  Erythrocyte membrane (Na ,  K )-ATPase is a sulfhydryl  enzyme and inhibition of
its activity  by lead  has been well documented  (Raghavan et al., 1981;  Secchi  et  al.,  1968;
Hasan et al.,  1967;  Hernberg  et al.,   1967b).   In  the study of Raghavan et al. (1981), enzyme
activity was  inversely correlated with membrane lead content  (p <0.001)  in lead workers with
or without  symptoms  of overt  lead toxicity,  while correlation with whole blood lead was poor.
With enzyme  inhibition,  there  is irreversible loss of potassium ion from the cell with undis-
turbed  input of sodium into the cell,  resulting in a relative increase in sodium.  Because the
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cells "shrink," there  is  a  net increase in sodium  concentration,  which likely results  in  in-
creased mechanical fragility and cell  lysis (Moore et al.,  1980).
     In lead-exposed  persons as well  as  in persons  with  a genetic deficiency of  the  enzyme
Py-5-N, reduced  activity  leads to impaired  phosphorolysis of the nucleotides cytidine  and
uridine phosphate, which are then retained in the cell and  cause interference with  the conser-
vation of  the  purine  nucleotides necessary for cellular energetics (Angle and Mclntire, 1982;
Valentine  and  Paglia,  1980).    A  more  detailed discussion of  lead's  interaction with  this
enzyme is presented in Section 12.3.2.3.
     In a  series  of experiments dealing with the hemolytic relationship of lead and vitamin E
deficiency  in  animals,  Levander et al.  (1980)  observed  that  lead exposure  exacerbates  the
experimental hemolytic anemia  associated  with vitamin  E  deficiency by  enhancing mechanical
fragility, i.e., by reducing cell deformability.   These workers note that vitamin E deficiency
is seen with children  having elevated blood lead levels, especially subjects having glucose-6-
phosphate dehydrogenase (G-6-PD) deficiency, indicating that the synergistic relationship seen
in animals may also exist in humans.
     Glutathione  is  a necessary factor  in erythrocyte function and structure.  In workers ex-
posed to lead, Roels et al.  (1975a) found  that there  is a moderate but significant decrease in
erythrocyte  glutathione  compared with controls.   This appears to reflect lead-induced  impair-
ment of glutathione synthesis.
12.3.2.3   Effects of  Lead on Pyrimidine-5'-Nuc1eotidase Activity and Erythropoietic Pyrimidine
Metabolism.  The  presence in lead  intoxication  of  basophilic stippling and  an anemia of hemo-
lytic  nature is  similar  to what  is  seen in  subjects  having  a genetically transmitted defi-
ciency  of  Py-5-N, an  enzyme mediating  the phosphorolysis  of the pyrimidine  nucleotides, cyti-
dine and uridine  phosphates.  With  inhibition, these  nucleotides accumulate  in the  erythrocyte
or reticulocyte,  ribonuclease-mediated  ribosomal  RNA  catabolism is  retarded  in maturing cells,
and  the resulting accumulation  of  aggregates  of incompletely degraded  ribosomal fragments  ac-
counts  for the phenomenon of basophilic stippling.
      In characterizing  the  enzyme Py-5-N,  Paglia  and Valentine  (1975)   observed  that  its
activity was particularly sensitive to  inhibition by  certain metals, particularly  lead, promp-
ting  further  investigation of the interplay between  lead intoxication  and disturbances  of
erythropoietic  pyrimidine metabolism.    Paglia et  al.  (1975) observed that  in subjects  occupa-
tional^  exposed to  lead but  having no evidence  of  basophilic stippling or  significant  fre-
quency of anemia, Py-5-N activity  was  reduced to about 50 percent of control  subjects  and was
most impaired (about 11 percent  of  normal) in one  worker with  anemia.   There was  a  general
 inverse correlation  between enzyme activity  and  blood  lead  level.   In  this report,  normal
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erythrocytes  incubated  with varying levels of  lead  showed  detectable inhibition at levels as
low  as 0.1-1.0 uM  and  showed consistent  50  percent inhibition at about 10  uM  lead.   Subse-
quently, Valentine  et al. (1976) observed that an individual with severe lead intoxication had
an 85  percent decrease in  Py-5-N activity, basophilic  stippling,  and accumulation of pyrimi-
dine  nucleotides,  mainly cytidine  triphosphate.   Because  these parameters  approached values
seen  in  the congenital  deficiency of Py-5-N, the data suggest a common etiology for the hemo-
lytic  anemia  and stippling  in both lead poisoning and the congenital disorder.
     Several  other  reports  of  investigations  of Py-5-N  activity and pyrimidine  nucleotide
levels in  lead workers have been published (Paglia  et  al., 1977;  Buc and Kaplan,  1978).   In
nine  workers  having overt  lead intoxication and  blood lead  values  of 80-160  ug/dl, Py-5-N
activity was  significantly  inhibited, and the pyrimidine nucleotides constituted 70-80 percent
of  the total   nucleotide  pool,  in  contrast  to  trace levels in  unexposed  individuals  (Paglia
et al., 1977).  In the study of Buc and Kaplan (1978), lead workers with or without overt lead
intoxication  all showed  reduced activity of Py-5-N,  which was  inversely correlated with blood
lead  when  the activity  was expressed as  a ratio  with  G-6-PD  activity to accommodate an  en-
hanced population of young cells due to hemolytic anemia.  Enzyme inhibition  was observed even
when other indicators of lead exposure were negative.
     Angle  and Mclntire (1978)  observed that  in  21 children  2-5  years  old with  blood lead
levels of 7-80 (jg/dl there was a negative linear correlation between Py-5-N activity and blood
lead (r = -0.60, p  <0.01).   Basophilic  stippling was only  seen  in  the child with the highest
blood  lead  value and  only  two  subjects  had  reticulocytosis.   While adults  tended  to show a
threshold for  inhibition  of Py-5-N  at a blood  lead  level  of 44 pg/dl or  higher, there was no
clear  response threshold  in these children.   In a related  investigation  with 42 children 1-5
years old with blood lead levels of <10-72 ug/dl, Angle  et al.  (1982) noted the following:  (1)
an  inverse  correlation  (r  = -0.64,  p <0.001)  between  the  logarithm  of  Py-5-N  activity  and
blood  lead; (2)  a  positive  log-log correlation between  cytidine phosphates  and blood lead in
15 of  these  children  (r =  0.89,  p <0.001);  and  (3) an  inverse  relationship in  12 subjects
between  the  logarithm  of  enzyme  activity and cytidine  phosphates   (r = -0.796,  p <0.001).
Study  of the  various   relationships  at low  levels  was made  possible by the  use  of anion-
exchange high  performance liquid chromatography.   In these studies, there was no threshold of
effects of  lead  on enzyme activity or cell nucleotide  content even below 10 ug/dl.   Finally,
there  was  a  significant  positive  correlation  of  pyrimidine nucleotide accumulation  and  the
accumulation of ZPP.
     In subjects undergoing therapeutic  chelation  with  EDTA, Py-5-N activity increased, while
there was no effect on pyrimidine nucleotides  (Swanson et al.,  1982).   This indicates that the
pyrimidine accumulation was  associated with the  reticulocyte.
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     The metabolic significance of Py-5-N activity inhibition and nucleotide accumulation with
lead exposure is that they affect erythrocyte membrane stability and survival  by alteration  of
cellular energetics  (Angle  and Mclntire, 1982).   In addition to  cell  lysis,  feedback inhibi-
tion of mRNA  and  protein synthesis may result through the alteration of globin mRNA or globin
chain synthesis by  denatured  mRNA.   It was noted earlier that disturbances in heme production
also affect  the translation  of globin  mRNA  (Freedman and  Rosman,  1976).  Hence,  these two
lead-associated disturbances  of  erythroid tissue  function  potentiate  the  effects of each
other.

12.3.3  Effects of Alkyl Lead on Heme Synthesis and Erythropoiesis
     In the discussion of alkyl lead metabolism in Chapter 10, Section 10.7, it was noted that
transformations of  tetraethyl  and tetramethyl lead iji  vivo  result in the generation not only
of  neurotoxic  trialkyl  lead metabolites but  also products  of further dealkylation, including
inorganic  lead.   One would  therefore expect  alkyl  lead exposure  to be  associated with,  in
addition to  other effects,  some of those  effects  classically related to  inorganic  lead expo-
sure.
     Chronic  gasoline  sniffing has been recognized as  a problem  habit among children in rural
or  remote  areas (Boeckx  et al., 1977; Kaufman, 1973).   When  such  practice  involves leaded gas-
oline,  the potential exists for  lead intoxication.  Boeckx  et al.  (1977)  conducted  surveys of
children  in  remote  Canadian  communities  for the prevalence  of gasoline  sniffing  and indi-
cations  of chronic lead exposure.  In one group of 43  children who  all  sniffed  gasoline, mean
ALA-D  activity was only 30 percent that of control subjects; there  was  a  significant correla-
tion between the  decrease in  enzyme  activity and the  frequency  of  sniffing.  A second survey
of  50  children revealed similar  results.  Two children having  acute lead  intoxication  associ-
ated with  gasoline sniffing  showed  markedly lowered hemoglobin,  elevated  urinary ALA,   and
elevated  urinary  coproporphyrin.   The authors estimated that more  than half  of the disadvan-
taged  children residing in rural  or  remote  areas of  Canada  may have chronic  lead  exposure  via
this habit;  this estimate  is  consistent with the estimate  of Kaufman (1973)  of  62 percent  for
children  in  rural  American  Indian communities in the  Southwest.
     Robinson (1978) described two cases  of pediatric lead  poisoning due  to  habitual  gasoline
sniffing,  one  of which showed basophilic stippling.  Hansen and Sharp  (1978) reported that a
young  adult with acute  lead  poisioning due  to chronic gasoline sniffing not only  had basophi-
 lic stippling, but  a  sixfold increase in urinary ALA, elevated urinary coproporphyrin, and an
EP   level  about fourfold above normal.   In  the reports  of  Boeckx et al.  (1977)  and Robinson
 (1978), increased lead  levels measured in urine in  the  course of chelation therapy indicated
that significant  amounts of inorganic lead were  present.

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12.3.4  The Interrelationship of Lead Effects on Heme Synthesis and the Nervous System
     Lead-associated disturbances  in  heme  biosynthesis  have been studied as a possible factor
in the  neurological  effects  of lead because of  (1)  the  recognized similarity between classic
signs of lead neurotoxicity and many, but not all, of the neurological components of the gene-
tically  transmitted  (autosomal  dominant) disorder acute  intermittent  porphyria,  and (2) some
unusual aspects of lead neurotoxicity.   Both acute porphyria and lead intoxication with neuro-
logical symptoms are variably accompanied by abdominal pain, constipation,  vomiting, paralysis
or  paresis,  demyelination, and  psychiatric disturbances  (Dagg  et al.,  1965;  Moore  et  al.,
1980;  Silbergeld and  Lamon,  1980).   According  to  Angle  and Mclntire  (1982),  some  of  the
unusual  features of  lead  neurotoxicity are consistent with deranged hematopoiesis:   (1) a lag
in production of neurological  symptoms; (2) the incongruity of early deficits in affective and
cognitive  function  with  the  regional  distribution  of  lead  in the  brain;  and  (3)  a better
correlation of  neurobehavioral deficits  with erythrocyte protoporphyrin than with blood lead.
The  third  feature,  it  should  be  noted,  is not  universally  the case  (Hammond et  al., 1980;
Spivey et al.,  1979).
     Available   evidence points  to  three  specific connections  between the  heme  biosynthetic
pathway and the  nervous system  in terms of  the  neurotoxic effects of lead:  (1) the potential
neurotoxicity  of the  heme precursor,  ALA; (2)  heme  deficiency  in  tissues external  to  the
nervous  system,  notably the liver;  and (3) jm  situ impairment  of heme  availability in  the
nervous system.
     While the  nature  and  pattern of the derangements in heme biosynthesis in acute porphyria
and  lead  intoxication  differ  in  many respects,  both involve  excessive systemic  accumulation
and  excretion  of ALA,  and  this common feature  has stimulated numerous studies of a connection
between hemato-  and  neurotoxicity.   lt\ vitro data (Whetsell et al., 1978) have shown that the
nervous  system  is  capable  of heme  biosynthesis  in the  chick dorsal root  ganglion.   Sassa et
al.  (1979) found that  the  presence of lead in  these  preparations increases production of por-
phyrinic material,  i.e., there is disturbed heme biosynthesis with accumulation of one or more
porphyrins and,  possibly,  ALA.   Millar et al.  (1970) reported inhibited brain ALA-D activity
in suckling rats exposed  to  lead, while Silbergeld  et  al.  (1982) observed similar inhibition
in brains  of adult  rats acutely exposed to  lead.  In the latter study, chronic lead exposure
was also associated with a moderate increase in brain ALA without inhibition of ALA-D, sugges-
ting an  extra-neural source  of  the heme precursor.   Finally,  Dieter and Finley (1979) showed
marked  ALA-D  activity  depression  in  brain regions of  avian  subjects.   Moore  and Meredith
(1976) administered ALA to rats and  observed that exogenous ALA can penetrate the blood-brain
barrier.  These reports suggest that ALA can either be generated j_n situ in the nervous system
or can enter the nervous system from elsewhere.

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     Neurochemical  investigations of ALA  action  in the nervous system have evaluated interac-
tions with  the  neurotransmitter gamma-aminobutyric acid (GABA).   Interference with  GABAergic
function by exposure  to  lead is compatible with such  clinical  and experimental  signs of lead
neurotoxicity as excitability,  hyperactivity,  hyperreactivity, and,  in severe lead  intoxica-
tion, convulsions (Silbergeld  and  Lamon,  1980).   Of particular  interest  is the  similarity in
chemical structures of ALA  and GABA;  these structures  differ  only in that ALA has a carbonyl
group on the alpha carbon and GABA has  a carbonyl group on the beta carbon.
     While  chronic  lead  exposure appears  to  alter neural  pathways involving  GABA function
(Silbergeld et  al.,  1979),  this effect cannot be  duplicated HI vitro using various levels of
lead (Silbergeld et al., 1980a).  This  suggests that lead does not impart the effect by direct
interaction or  that  an  intact multi-pathway system  is  required.  In vitro studies (Silbergeld
et  al.,  1980a;  Nicoll,  1976) demonstrate  that  ALA can displace  GABA  from synaptosomal mem-
branes  associated  with  synaptic  function of  the  neurotransmitter  on  the GABA  receptor, but
that  it  is  less potent than  GABA by  a  factor  of 103-104,  suggesting  that  levels  of ALA
achieved even with severe intoxication may not be effectively competitive.
     A more significant  role  for ALA in lead neurotoxicity may well  be  related to the observa-
tion that  GABA  release  is subject  to  negative feedback control through presynaptic  receptors
on  GABAergic  terminals  (Snodgrass,  1978; Mitchell  and Martin, 1978).   Brennan and Cantrill
(1979)  found  that ALA  inhibits K+-stimulated release  of GABA from preloaded synaptosomes by
functioning as  an  agonist at  the presynaptic  receptors.  The  effect is evident  at 1.0 (jM ALA,
and  it  is abolished by  the  GABA  antagonists  bicuculline and  picrotoxin.   Of  interest also is
the  demonstration  (Silbergeld et al. ,  1980a)  that synaptosomal release of  preloaded 3H-GABA,
both  resting and K  -stimulated,  is also inhibited  in  animals chronically treated  with  lead,
paralleling the iji vitro data of  Brennan  and Cantrill  (1979) using ALA.
     Silbergeld et  al.   (1982)  described  the  comparative effects of  lead  and  the  agent  succi-
nylacetone,  given  acutely or  chronically to adult rats,  in  terms  of disturbances  in heme syn-
thesis  and neurochemical indices.   Succinylacetone,  a  metabolite that can  be isolated from the
urine  of patients with  hereditary  tyrosinemia (Lindblad et al.,  1977),  is a  potent inhibitor
of  heme synthesis,  exerting  its  effect  by  ALA-D inhibition  and derepression of  ALA synthetase
(Tschudy et al.,  1980,  1981).   In vivo,  both  agents showed  significant inhibition of high
affinity Na -dependent  uptake  of  14C-GABA  by  cortex,  caudate, and substantia nigra.  However,
neither agent affected  GABA uptake jm  vitro.   Similarly,  both chronic and acute  lead treatment
and chronically administered succinylacetone  reduced the seizure threshold to the  GABA antago-
nist,  picrotoxin.  While these agents  may involve  entirely  different mechanisms  of toxicity to
the GABAergic  pathway,  the  fact  remains that two  distinct  potent inhibitors of the heme bio-
synthetic pathway  and  ALA-D, which  do  not  impart a common  neurochemical  effect  by  direct
action on a neurotransmitter function, have a common neurochemical action j_n vivo.
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     Several  important  studies  in experimental systems strongly  indicate  that the key factor
in the  connection between heme biosynthesis and neurotoxicity may very well be a reduction in
the  levels  of heme itself,  rather  than  behavior of its precursor, ALA.   Badawy (1978)  first
described  the role  of  tryptophan  pyrrolase  in the  relationship of  heme  biosynthesis  and
neurotoxic manifestations  of the  hepatic porphyrias.  Using a porphyric rat model, Litman and
Correia (1983) have reported that lead and the porphyrinic agent DDEP are both associated with
inhibition of the hepatic heme-requiring enzyme system, tryptophan pyrrolase, via reduction of
the  free  hepatic  heme pool.   This  results  not only in elevated plasma tryptophan but also in
significantly elevated  brain levels of tryptophan, serotonin, and 5-hydroxyindoleacetic  acid.
Of  particular interest is  the  effect  of  subsequent  infusion  of  heme,  which  reduced  the
elevated  levels  of these substances to  normal  amounts.  Since,  as noted by  the  authors,  heme
does not  penetrate  the  blood-brain barrier, heme repletion had its effect in the liver.   This
was  confirmed by increases  in  both  hepatic  heme  content  and  enzyme  activity after  heme
infusion.    These  data  are relevant to  some  of  the common  features  of acute  porphyria  and
disturbances in tryptophan metabolism noted by Litman and Correia (1983):

     (1)  Elevated tryptophan  levels  have been associated with human  hepatic encephalo-
          pathy.
     (2)  Elevation in  circulating  tryptophan  in rats produces structural  alterations of
          brain astrocytes, oligodendroglia, and neurons,  as well  as Purkinje cell degen-
          eration  and axonal  wasting.   These neurohistological  changes  resemble those
          seen in victims of acute porphyria attacks.
     (3)  The pharmacological effects of serotonin in the central  nervous system resemble
          the neurological manifestations of acute porphyria attacks.
     (4)  Administration  of  tryptophan and  serotonin  to humans  yields  symptoms greatly
          overlapping  those  of  acute  porphyria  attacks:    psychomotor  disturbances,
          abdominal pain, nausea,  and dysuria.
     (5)  Porphyric subjects show abnormal tryptophan metabolism and urinary excretion of
          large amounts of 5-hydroxyindoleacetic acid.

     In the  above  study, phenobarbital  induction  of  the enzyme  system  was employed.   The
behavior of lead alone has not been investigated.  In studies related to heme reduction in the
nervous system itself,  Whetsell  and Kappas (1981) and Whetsell et al.  (1984) showed that co-
administration of heme  and lead prevented  most  of  the  neuropathic responses  to  lead in cul-
tured mouse  dorsal  root  ganglion  seen  with lead alone (see  Section 12.3.13).   These results
strongly suggest that reduced heme levels in the neural  tissue due to the presence of lead are
associated with the  adverse  effects observed.   Because this tissue culture system is known to
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carry out heme  biosynthesis  (Whetsell  et al., 1978; Sassa  et al.,  1979),  it is highly likely
that lead impairs neural  heme biosynthesis.
     Human data  relating the hemato- and neurotoxicity  of  lead are limited.   Hammond  et  al.
(1980) reported  that  the best correlates of the frequency of neurological  symptoms in 28 lead
workers were  urinary and  plasma  ALA,  as well  as  blood lead levels,  both of  which  showed  a
higher  correlation  than  EP.   These  data  support a  connection  between heme  biosynthesis
impairment and  neurological  effects  of ALA.  Of interest here is the clinical report of Lamon
et al.  (1979)  describing the effect of hematin [Fe(III)-heme] given parenterally to a subject
with  lead intoxication.    Over  the  course  of treatment  (16  days),  urinary coproporphyrin  and
ALA  significantly dropped and neurological  symptoms  such  as  lower  extremity  numbness  and
aching  diminished.   Blood  lead  levels  were  not  altered  during  the  treatment.   Although
remission of  symptoms in  this  subject may  have been spontaneous,  the outcome  parallels that
observed  in  hematin treatment  of subjects  with acute porphyria  in  similar  reduction of heme
indicators and relief of symptoms (Lamon et al., 1979).
     Taken collectively, all of the available data  suggest the following:

     (1)  Delta-arainolevulinic  acid formed jji  situ or entering  the  brain  may  well £e
          neurotoxic  by  impairing  GABAergic  function   in  particular.   It  inhibits K  -
          stimulated  GABA release  by  interaction  with  presynaptic receptors,  where ALA
          appears  to be  particularly  potent at  very  low  levels  (1.0 urn),  based on  i_n
          vitro  results.
      (2)  Decreased  levels of heme  in  the liver  due to lead  exposure inhibit  the  activity
          of  tryptophan  pyrrolase,  resulting in elevations  of tryptophan, serotonin, and
          5-hydroxyindoleacetic  acid in brain.  Such increases  are reversed by  infusion
          of  heme.
      (3)  Heme  reduction in neural  tissue, as  a result of  lead's  effect  on  heme biosyn-
          thesis,  is associated with tissue  injury, such injury  is  prevented by  heme co-
          administration.

 12.3.5   Interference with Vitamin D  Metabolism  and Associated Physiological  Processes
      A  new  dimension to  the  human  toxicology of  lead is presented by lead's interaction  with
 the  vitamin  D-endocrine system.   Recent evidence of lead-induced  disturbances  in  vitamin D
 metabolism  in humans and  animals,  particularly with respect to  lead-related reductions in the
 biosynthesis  of the hormonal metabolite 1,25-dihydroxyvitamin D (1,25-(OH)2D), are of special
 concern for two reasons:   (1)  1,25-(OH)2D  appears to serve many more  physiological roles  than
 just mediation of calcium homeostasis  and  metabolic function, and (2) even moderate levels  of
 lead exposure  in  children  are  associated  with  vitamin D  disturbances that parallel  certain
 genetic metabolic  disorders and other  disease  states,  as  well as  severe kidney dysfunction.
      It appears likely  that lead-induced  reductions in heme underlie  the effects seen in the
 vitamin  D-endocrine  system.   This  origin  would account for  the  similarities  in "thresholds"
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for  the  effects  of  lead on  both erythrocyte  protoporphyrin  accumulation and  decreases  in
levels  of 1,25-(OH)2D.   It also typifies a  cascade  of biological effects among various organ
and  physiological  systems  of  the body,  effects that  can  ultimately  encompass  the  entire
organism  (this is graphically depicted  in Chapter 13).   Collectively,  the interrelationships
of calcium and lead metabolism as well as lead's effects on 1,25-(OH)2D provide one molecular
and  mechanistic  basis  for the classic observation by Aub et al. (1926) that "lead follows the
calcium stream."

12.3.5.1   Relevant  Clinical Studies.   As  initially  reported by Rosen et al.  (1980),  lead in-
toxicated  children  with  blood lead concentrations of  33-120  ug/dl  have  a marked reduction in
serum levels of 1,25-(OH)2D.   The most striking decrease in circulating 1,25-(OH)2D levels was
found  in  children whose  blood lead  levels  were greater than  62 ug/dl.   Nonetheless,  highly
significant  and   profound  depressions in  circulating  1,25-(OH)2D  levels  were found also  in
children  whose blood lead concentrations  ranged from 33 to 55  ug/dl.   Children whose blood
lead values  were  above  62 ug/dl  also showed a significant decrease in serum total calcium and
ionized calcium (Ca), while  serum parathyroid hormone (PTH) concentrations were significantly
elevated.   Under  these conditions,  and in the face of decreased dietary intake of calcium,  it
is anticipated that  the  recognized modulators of 1,25-(OH)2D synthesis  (PTH,  Ca2+, inorganic
phosphorus [P.])  would enhance production of the vitamin D hormone.  Since there was in  fact a
reduction  in circulating  concentrations  of 1,25-(OH)2D, this suggests that production  of the
vitamin D hormone was actually impaired.
     On the  basis of significant negative correlations between  blood levels of lead and serum
levels of  1,25-(OH)2D and negative correlations between erythrocyte protoporphyrin  and 1,25-
(OH)2D  in  children with  blood  lead concentrations  of 33-120  ug/dl,  it  is reasonable  to
conclude that  the lead  ion impairs the production of  1,25-(OH)2D3,  as aluminum does in chil-
dren undergoing total parenteral nutrition (Rosen and Chesney, 1983).
     The 1-hydroxylation step to produce the vitamin 0 hormone is carried out in the mitochon-
dria  of the  renal  tubule by  a complex cytochrome  P-450 enzyme  system (Rosen  and  Chesney,
1983).  The  ingredients  of this  enzyme  system include intact mitochondria,  Krebs  cycle sub-
strates,  cytochrome P-450 electron  transport,  oxidative  phosphorylation,  and generation  of
NADPH (nicotinamide  adenine  dinucleotide  phosphate,  reduced).  The biosynthesis  of  the vita-
min D hormone  is  controlled  in large part by the functional  integrity of mitochondria,  by the
ionic (Ca,  P.) microenvironment of the extracellular  fluid,  and by the uptake of  calcium  by
mitochondria (including the  delicate  homeostasis characteristic of intracellular calcium con-
centrations  and  calcium  pumps).   It  is  clear,  therefore,  based upon lead's  toxic  effects  on
mitochondria, cellular energetics, and cytochrome P-450 electron transport in several  studies,
including  some on  children  (Saenger  et al.,  1984;  Piomelli et  al. , 1982),  that lead  most
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likely  impairs  the  1-hydroxylase enzyme  system,  although  altered  peripheral  metabolism  of
1,25-(OH)2D cannot be completely ruled out.   As noted in Section 12.5,  furthermore,  lead  inhi-
bits  renal  ferrochelatase  with accumulation of EP leading  to a reduction in the kidney  heme
pool and reduced availability of heme for renal 1-hydroxylase (Fowler et al.,  1980).
     Lead's  impairment of  the 1-hydroxylase  enzyme system  in  lead intoxicated children  is
strongly  supported by  additional information:   1)  1,25-(OH)2D levels  in serum returned  to
normal  values  within two  days following chelation  therapy, while  no  changes  were  found  in
25-(OH)D  levels,  and 2) a  strong negative  correlation between 1,25-(OH)2D  values  and  blood
lead was found over the entire range (12-120 ug/dl) of blood  lead levels measured in the  study
(Rosen  etal.,  1980;  Mahaffey etal.,  1982).  Furthermore,  no change  in  the slope of the
regression  line  between 1,25-(OH)2D and blood lead  was found for blood  lead values  above  or
below  30 ug/dl  (Mahaffey  et al. ,  1982).   These findings  provide considerable support for the
view  that  lead  interferes with normal ionic transport  in cells and with the functional integ-
rity  of mitochondria that carry  out  this  1-hydroxylation.   In terms of ionic transport, cur-
rent  information  indicates that  increasing  extracellular and intracellular concentrations  of
calcium depress  production  of  the   vitamin D hormone (Rosen  and Chesney,  1983).   If   renal
tubule  cells accumulate high concentrations of calcium after exposure to lead, as do hepato-
cytes  (Pounds  et al., 1982a, Pounds  and Mittelstaedt,  1983), osteoclasts  (Rosen, 1983, 1985),
and brain cells (Silbergeld and  Adler,  1978), renal tubule  cells may  consequently "turn off"
1,25-(OH)2D production.   Such an effect is  likely to be reversible when  lead  is decreased in
the extracellular fluid,  as  it is in  children  after  therapy with CaNa2EDTA.
      In summary,  lead's effect(s) on  the complex  1-hydroxylase enzyme  system may be  expressed
 in one or  several components  of  the  enzyme  (e.g., cellular energetics,  integrity of  mitochon-
 dria).   Simultaneously,  lead may  interfere with ionic regulation of  1,25-(OH)2D3 biosynthesis.
 The fact that  such effects can be reversed,  at least insofar as 1,25-(OH)2D  levels  may recover
 to normal  values  after chelation therapy,  does  not suggest  that  these effects of  lead  are
 necessarily transient  or  subject to  physiological  adaptation.   Thus  far,   reversibility  has
 been known to  occur only after medical intervention.
 12.3.5.2    Experimental Studies.    Smith   et al.    (1981)   observed  depressions   of  plasma
 1,25-(OH)2D in rats  fed  0.82 percent lead as lead  acetate.   Moreover,  lead ingestion totally
 blocked the intestinal calcium  transport  response to  the  vitamin D hormone.   Though the dose
 of lead and the  resulting blood lead concentrations  were  high in this study,  it  confirms  the
 effect(s)  of lead  on vitamin D metabolism reported  in children.   A recent study demonstrated
 directly  that  renal  production and tissue  levels of the vitamin 0 hormone  were reduced in  a
 dose-related fashion in chicks  fed  a diet  supplemented with  lead (Edelstein etal.,  1984).
 Previous studies have shown that vitamin D and 1,25-(OH)2D3 enhance lead acetate absorption in
 the distal  small  intestine of the rat, whereas  vitamin D-dependent calcium absorption occurs
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in  the  proximal  duodenum  (Smith et al.,  1978;  Mahaffey et  al.,  1979).   It  is likely  that
vitamin D affects  lead  absorption  in  a manner somewhat different  from  the manner  in which  it
affects  calcium absorption  (Smith  et al.,  1978;  Mykkanen  and  Wasserman,  1982).   It is  of
interest that  high  doses  of vitamin D and 1,25-(OH)2D3 do  not markedly increase lead  absorp-
tion above that achieved with physiological doses (Smith et  al.,  1978).
12.3.5.3  Implications of Lead Effects on Vitamin D Metabolism
12.3.5.3.1  Direct Metabolic Consequences of Vitamin D Metabolism Interference  in Children.   A
lower daily intake of calcium, as observed  in lead  intoxicated children  (Sorrell  et  al. , 1977;
Rosen et al., 1980), accompanied by a relative decrease in l,25-(OH)2D-stimulated formation  of
calcium-binding protein (CaBP),  may  permit lead to compete  favorably with calcium  for  mucosal
proteins and similar  absorption  sites  in the intestine.   In addition, experimental  study  with
animal CaBP  has demonstrated  a much greater affinity of this intestinal protein  for lead  than
for  calcium  (Fullmer et  al., 1985).   Such  findings help  explain the  negative  correlations
found between  calcium intake  and blood  lead  and between  serum  calcium  and blood  lead values
(Sorrell et al., 1977).
     Furthermore,  depression  in  serum  ionized calcium during lead intoxication (Rosen  et  al.,
1980) may  enhance  the  movement  of lead  from hard  tissue  to  critical organ sites  in  soft
tissues.    In  bone  organ  culture,  decreasing  the  concentration of  calcium in  the  medium
enhances mobilization  of  previously  incorporated  radioactive lead from bone  explants  to the
medium (Rosen  and  Markowitz,  1980).   Among other things,  these  findings indicate that  reduced
1,25-(OH)2D  levels  do not  serve  to "protect" soft  target organs  such as brain  and kidney  from
lead deposition by  sequestering  the  metal  in  bone.   Further, empirical  support  for this  con-
clusion may be found in the results of Smith et al. (1981),  who  reported no consistent  differ-
ences in  rats' kidney  lead content  as a  function of the presence or absence of  a vitamin D
supplement  in  the  diet.   These  investigators  also  found no significant  differences  in the
blood lead concentrations of the rats as a function of vitamin D  supplementation.   In summary,
there is little reason to suppose that reduced levels of 1,25-(OH)2D  might  function as  part  of
a  negative  feedback process  to  reduce  further  absorption  of lead  or  to mitigate  its toxic
effects on various target organs.
12.3.5.3.2     Other Childhood Diseases Associated with a Reduction in Circulating 1.25-(OH)?D
as a Reflection of Depressed Biosynthesis.   At blood lead levels  of 33-55 ug/dl (Rosen  et  al.,
1980), 1,25-(OH)2D  levels  are reduced to  levels comparable  to those observed in children who
have severe  renal  insufficiency  with loss  of  about  two-thirds of their normal renal  function
(Rosen and Chesney,  1983;  Chesney et al.,  1983).  Also, at  blood lead levels  of  33-120 ug/dl,
analogous depressions in 1,25-(OH)2D concentrations (S20 pg/ml)  are found in:
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     (1)   Vitamin  D-dependent  rickets,  type  I--an  inborn error of vitamin D metabolism in
          which  the 1-hydroxylase  enzyme system  (or  a component  thereof)  is virtually
          absent;
     (2)   Oxalosis—an inborne  error  of  metabolism  in  which  calcium oxalate crystals
          are deposited throughout the body,  including the  kidney,  and result in chronic
          renal  insufficiency,
     (3)   Hormone-deficient hypoparathyroidi sin—thought to  be  an  autoimmune disorder,
          hereditary   in  some  cases,  that  is  characterized by parathyroid hormone  defi-
          ciency and,  as  a result,  decreased production of the vitamin D hormone;
     (4)   Aluminum intoxication  in children  undergoing  total  parenteral  nutrition—has
          occurred when  the casein  hydrolysates  used were contaminated with aluminum.

These disorders  are reviewed by Rosen and Chesney  (1983)  and Chesney et al.  (1983).
12.3.5.3.3   Physiological Functions  of 1,25-(OH)2D3 at the Cellular Level.    The   vitamin  D-
endocrine system  is responsible  in large part for the maintenance of extra-  and  intracellular
calcium  homeostasis  (Rasmussen and  Waisman,  1983;  Wong,  1983;  Shlossman etal.,  1982;  Rosen
and Chesney,  1983).   As  a result, the integrity of cells of diverse function is  preserved,  as
are numerous  calcium-mediated  functions.   It  is  known that calcium,  an important participant
in the hormonal  responses of many target cell systems (Rasmussen and Waisman, 1983), acts not
only as a second messenger, but also as a modulator of cyclic nucleotide metabolism.  The tem-
poral and spatial regulation of cellular calcium  is exceedingly important in the response of a
variety of cells to hormonal and electrical stimuli.
     Lead alone  (without hormones) produces an overamplification of calcium  influx in hepato-
cytes  (Pounds etal., 1982a),  osteoclasts (Rosen, 1983, 1985),  and  brain slices (Silbergeld
and Adler,  1978)  at   relatively low  concentrations.   As  a result,  calcium-mediated cell func-
tions  are perturbed  (Pounds et al.,  1982b).   Based upon these findings,  it is  reasonable to
conclude  that modulation  in cellular calcium  metabolism  induced  by  lead  at relatively low
concentrations  may have  the  potential of disturbing  multiple  functions of  different tissues
that depend  upon  calcium as a  second messenger.   Perturbations  in cellular calcium homeostasis
may  thereby  result from the  effects  of lead  alone;  but  these  effects  may be enhanced when
coupled  with decreased  production of 1,25-(OH)2D3 and  reduction  in serum (and extracellular
fluid) ionized calcium values  observed in  lead  intoxicated  children.
     Calmodulin  is of central importance as an  intracellular  calcium receptor protein.  Its
nearly  universal  distribution in  mammalian cells emphasizes further that calcium  serves as a
"universal"  second messenger.   As  such,  calmodulin  regulates several  enzyme  systems  and trans-
port  processes.   The  list  of  calcium-sensitive reactions modulated by the  calmodulin-calcium
complex  is  rapidly expanding  (see review by  Cheung,  1980).  Recently,  it has been shown that

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lead  can replace  calcium  in the activation of  calmodulin-sensitive  processes  (Habermann et
al., 1983), including potassium loss from erythrocytes (Goldstein and Ar, 1983).   Though at an
early  stage of investigation, it is conceivable that a molecular model of  lead  toxicity may
include  (in  addition  to  those  processes cited  above)  intracellular occupation  of  calcium-
binding  sites  on  calmodulin.  Since  calmodulin regulates multiple  cell  activities,  such  a
mechanism  may underlie  some  of  the diverse  effects of  lead.   Lead alone  and  lead's  inter-
action^) with  calmodulin  and intracellular calcium homeostasis are inherently coupled  to the
vitamin  D-endocrine system.
12.3.5.3.4  Cell Differentiation/Maturation.   Tumor cell  lines  possess cytosol  receptors to
which 1,25-(OH)2D3 binds specifically (Tanaka et al., 1982; Shiina et al.,  1983;  Honma et al.,
1983).   Human promyelocytic leukemia cells (HL-60) can be induced to differentiate rn vitro by
1,25-(OH)2D3.    Differentiation-associated properties,  such  as  phagocytosis  and C3  rosette
formation, were induced by as little as 0.12 nM 1,25-(OH)2D3.   As cells  exhibited differentia-
tion, the  viable cell  number was decreased to  less  than half of the control  (Tanaka et al.,
1982).   A specific cytosol  protein that bound 1,25-(OH)2D3 was found in  these HL-60 cells; its
physical and  biochemical properties closely  resembled  those  found in  "classical"  vitamin  D
target  tissues.   These  and  other  studies noted above  indicated  that 1,25-(OH)2D3  induced
differentiation of HL-60 cells by a mechanism similar to that proposed  for the classical con-
cept  of steroid hormone  action.   This  common  mechanism of  steroid  hormone action  includes
binding  of  hormone to  a cytosol  receptor (to form  a hormone-receptor complex)  and subsequent
movement of this complex into the nucleus where  it binds to chromatin.
     A recent study by  Honma et  al.  (1983) showed that the survival time of syngeneic SL mice
inoculated  with murine  myeloid  leukemia cells  (ML) was  markedly  prolonged by  l-25-(OH)2D3
treatment (12.5-50 pmol  per mouse).   Evidence indicated that  induction  of differentiation of
ML cells into  macrophages jn vitro was  correlated with its effect in prolonging survival time;
and it was  suggested  that  the role of  1,25-(OH)2D3  in  decreasing leukemogenicity of ML cells
HI vivo  is  due  to  its effect in  suppressing  proliferation and inducing differentiation of ML
cells iji vitro (Honma et al., 1983).
     It  is  evident, therefore, that  the differentiation in HL-60 cells  (and other cell  lines)
caused  by  1,25-(OH)2D3  is  a manifestation of  the  normal  action of this hormone to  elicit
maturation of myeloid  stem cells  into  macrophages.   Because macrophages are thought to  be the
precursor  of  bone  resorbing osteoclasts, this  is  a  logical  mechanism whereby  1,25-(OH)2D3
brings about calcium resorption/homeostasis through recruitment of cells competent in bone re-
modeling.  Moreover, parathyroid  hormone is  thought to act both  directly  to stimulate  osteo-
clast  production  from myeloid precursors and  on T-lymphocytes to cause  the elaboration  of
putative osteoclast-enhancing factors.   It  appears,  therefore,  that  the  vitamin 0  hormone
regulates calcium homeostasis and also  participates directly in bone turnover by  orchestrating
the population of cells within bone.
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12.3.5.3.5   Immunoregulatory Role of the Vitamin D Hormone.   The  widespread  distribution  of
receptors for  1,25-(OH)2D3  in tissues  not thought to  play a role in mineral metabolism  has
made  it  clear  that  the vitamin D  hormone plays a  wider  biologic  role  than was  previously
thought  (Kadowaki  and Norman,  1984a,b; Stumpf  et al.,  1982;  Clark et al., 1981; Gel bard  et
a!.,  1980).   Receptors for 1,25-(OH)2D3 are  present in normal human monocytes  and malignant
lymphocytes  (Provvedini  et al.,  1983;  Bhalla  et al. ,   1983).   It has  also  been  shown  that
macrophages  from vitamin D-deficient mice  have impaired phagocytic and inflammatory responses
correctable by 1,25-(OH)2D3 repletion (Bar-Shavit et al., 1981).
     T and  B lymphocytes  obtained from normal humans also  expressed the 1,25-(OH)2D3 receptor
after  the   lymphocytes  had  been  activated  by  mitogenic  lectins  and  Epstein-Barr  virus
(Provvedini  et al., 1983; Bhalla et al., 1983).  The mitogenic  lectin phytohemagglutinin (PHA)
stimulates  T  lymphocyte  proliferation and induces  the production  of various  lymphokines,
including  interleukin-2 (IL-2), which  is  important  for the growth of T  cells.   Recently, it
has  been demonstrated  that  1,25-(OH)2D3   (at  picomolar concentrations) inhibits  the  growth-
promoting  lymphokine   IL-2 and  the proliferation of  PHA-stimulated lymphocytes  obtained  from
normal humans  (Tsoukas et al.,  1984).   These  results confirm  and  extend earlier evidence  that
1,25-(OH)2D3  receptors  are  expressed in T   lymphocytes  activated  with mitogenic  lectins
(Provvedini  et al., 1983; Bhalla et al., 1983).  In  light of  suggestions that calcium translo-
cation  is involved in the mitogen-induced activation  of lymphocytes and  in view of the well-
recognized  calcitropic effects  of 1,25-(OH)2D3  on mineral-dependent  target tissues, it may be
that the suppressive  effect of  the  vitamin D  hormone on IL-2  is mediated by calcium transloca-
tion (Tsoukas et al., 1984).   However  mediated, this effect  demonstrates  the immunoregulatory
role of  1,25-(OH)2D3  and,  thus,  another  possible means  by  which lead could affect  immunity
(see Section 12.8).

12.3.6  Summary and Overview
 12.3.6.1  Effects of  Lead on Heme Biosynthesis.  The effects  of  lead on heme biosynthesis are
well known  because  of their  clinical   prominence and the numerous studies of such effects in
 humans  and  experimental  animals.  The process of  heme biosynthesis starts with  glycine and
 succinyl-coenzyme A,  proceeds  through  formation of protoporphyrin IX, and culminates  with the
 insertion of  divalent iron  into the porphyrin ring to form heme.   In addition to being a con-
 stituent of hemoglobin,  heme  is the prosthetic group of many tissue hemoproteins having vari-
 able functions, such as myoglobin, the P-450 component of  the mixed-function oxygenase system,
 and  the cytochromes  of cellular energetics.   Hence, disturbance  of heme biosynthesis by  lead
 poses the potential for multiple-organ toxicity.
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     In  investigations  of  lead's  effects on  the  heme synthesis pathway,  most  attention has
been  devoted  to  the following:   (1)  stimulation  of mitochondrial  delta-aminolevulinic  acid
synthetase  (ALA-S),  which  mediates  formation of  delta-aminolevulinic  acid (ALA);  (2) direct
inhibition  of  the cytosolic enzyme, delta-aminolevulinic acid dehydrase  (ALA-D), which cata-
lyzes  formation  of porphobilinogen from two  units  of  ALA;  and (3) inhibition of insertion of
iron (II) into protoporphyrin IX to form heme, a process mediated by ferrochelatase.
     Increased ALA-S  activity  has  been found  in lead  workers  as well as in lead-exposed ani-
mals,  although an  actual decrease in enzyme activity has also been observed in several  experi-
mental  studies  using  different exposure methods.    It  appears, then,  that the effect on ALA-S
activity may depend  on  the nature of  the  exposure.   Using rat liver cells  in culture, ALA-S
activity was stimulated jji vitro at lead levels as low as 5.0 uM or 1.0 ug/g preparation.   The
increased activity was due to biosynthesis of more enzyme.   The blood lead threshold for stim-
ulation  of  ALA-S  activity  in  humans,  based  on a  study  using  leukocytes  from  lead workers,
appears  to  be  about 40 ug/dl.   Whether this  apparent threshold applies to  other tissues de-
pends  on  how well  the  sensitivity of  leukocyte  mitochondria mirrors  that  in other systems.
The relative impact  of  ALA-S activity  stimulation  on  ALA  accumulation  at lower  lead exposure
levels appears to be  much less than the  effect of ALA-D activity inhibition.  ALA-D activity
is  significantly  depressed at  40  pg/dl blood lead, the  point  at which ALA-S  activity  only
begins to be affected.
     Erythrocyte  ALA-D  activity  is  very sensitive to  inhibition  by  lead.   This  inhibition is
reversed by  reactivation  of the sulfhydryl group with agents such as dithiothreitol, zinc, or
zinc and glutathione.   Zinc levels that achieve reactivation,  however,  are well  above physio-
logical  levels.   Although zinc appears to  offset  the inhibitory effects of lead observed in
animal  studies and in human erythrocytes jin vitro, lead workers  exposed to both  zinc and lead
do not  show significant changes in the relationship of ALA-D activity to blood lead when com-
pared with  workers exposed  just to lead.  Nor does  the range of physiological zinc levels in
nonexposed  subjects affect  ALA-D activity.   In contrast, zinc deficiency  in animals signifi-
cantly inhibits ALA-D activity,  with  concomitant accumulation of ALA  in urine.   Because zinc
deficiency  has also  been  demonstrated to increase  lead absorption,  the possibility  exists for
the following dual effects of such  deficiency on ALA-D activity:   (1) a direct effect on acti-
vity due  to reduced  zinc  availability; and (2) increased lead absorption  leading  to  further
inhibition of activity.
     Erythrocyte  ALA-D  activity appears  to  be inhibited  at virtually all  blood lead levels
measured so  far,  and  any threshold for this effect in either adults  or children  remains to be
determined.   A further  measure  of  this enzyme's sensitivity to lead  is  a report  that rat bone
marrow suspensions show  inhibition  of ALA-D activity by lead  at a level of 0.1 ug/g  suspen-
sion.    Inhibition of ALA-D activity  in erythrocytes apparently  reflects a  similar  effect in
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other tissues.  Hepatic ALA-D  activity in lead workers was inversely correlated with  erythro-
cyte activity  as  well as  blood lead  levels.   Of significance  are experimental animal  data
showing that (1) brain ALA-D activity is inhibited with lead exposure,  and (2)  this  inhibition
appears to  occur  to  a greater extent in developing animals than in adults,  presumably reflec-
ting greater  retention of lead in  developing  animals.   In the avian  brain, cerebellar  ALA-D
activity is affected  to  a greater extent than that of the cerebrum and, relative to lead con-
centration, shows inhibition approaching that occurring in erythrocytes.
     Inhibition of  ALA-D activity  by  lead  is  reflected by elevated levels  of its  substrate,
ALA, in  blood,  urine, and soft tissues.  Urinary ALA is employed extensively as an indicator
of excessive lead exposure in  lead workers.   The diagnostic value of this measurement in pedi-
atric  screening,  however,  is  limited when  only  spot urine collection  is done; more satisfac-
tory  data  are  obtainable with  24-hr collections.   Numerous  independent studies  document  a
direct  correlation  between  blood  lead and  the logarithm of urinary  ALA  in human  adults and
children;  the blood  lead  threshold for  increases in urinary ALA  is  commonly accepted  as 40
pg/dl.  However,  several studies of lead workers  indicate  that the correlation between urinary
ALA  and blood  lead  continues below this value;  one study found that  the  slope of the dose-
effect curve  in lead  workers depends on the  level  of exposure.
     The  health significance of lead-inhibited  ALA-D activity and accumulation  of ALA at  lower
lead  exposure levels  is controversial.   The "reserve capacity" of  ALA-D  activity is  such  that
only  the  level  of  inhibition associated with  marked accumulation of  the enzyme's substrate,
ALA,  in accessible indicator  media may be  significant.  However,  it  is  not possible to  quan-
tify  at lower levels  of  lead  exposure the  relationship of urinary  ALA to target tissue  levels
or to relate the potential  neurotoxicity of ALA  at  any  accumulation  level  to levels  in  indi-
cator  media.   Thus,  the  blood lead threshold  for neurotoxicity  of ALA may be  different  from
that  associated with increased urinary excretion of  ALA.
      Accumulation of  protoporphyrin  in erythrocytes of lead-intoxicated  individuals has  been
 recognized since the 1930s, but it has  only  recently been possible  to  quantitatively  assess
 the nature of this  effect via development of sensitive, specific microanalysis methods.   Accu-
 mulation of protoporphyrin  IX in  erythrocytes results from impaired placement of iron (II)  in
 the porphyrin moiety  in  heme  formation,  an intramitochondrial  process mediated by  ferrochela-
 tase.   In  lead exposure,  the  porphyrin acquires a zinc ion in lieu of native iron, thus form-
 ing zinc  protoporphyrin  (ZPP), which is tightly  bound in available heme pockets for the life
 of the erythrocytes.  This  tight sequestration contrasts with the relatively mobile nonmetal,
 or free, erythrocyte protoporphyrin (FEP) accumulated  in the congenital disorder erythropoiet-
 ic protoporphyria.
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     Elevation of  erythrocyte  ZPP  has been extensively documented as exponentially  correlated
with blood lead in children and adult lead workers and is currently considered one of  the  best
indicators of  undue lead  exposure.   Accumulation of  ZPP only occurs in  erythrocytes  formed
during lead's  presence  in  erythroid tissue; this results  in  a  lag of at  least  several weeks
before its buildup can be measured.  The  level  of  ZPP accumulation in erythrocytes  of newly
employed  lead  workers  continues to  increase after  blood lead has already reached  a  plateau.
This influences the  relative  correlation of ZPP and blood lead in workers  with short  exposure
histories.  Also,  the ZPP level in blood declines much more slowly than blood lead,  even after
removal from exposure  or after a drop in blood lead.   ZPP level  also appears to be  a  more re-
liable  indicator  of  continuing intoxication  from lead  resorbed  from  bone  in former  lead
workers long removed from heavy lead exposure.
     The threshold for  detection  of lead-induced ZPP  accumulation is affected by the  relative
spread of  blood  lead and corresponding ZPP values  measured.   In young children (<4  yr old),
the ZPP elevation  associated  with  iron-deficiency anemia must also be considered.   In adults,
numerous  studies  indicate  that the  blood lead  threshold  for ZPP  elevation is about 25-30
ug/dl.   In children 10-15 years old, the threshold is  about 16 ug/dl; for this age group,  iron
deficiency is  not  a  factor.   In one  study, children  over 4 years old showed the same thresh-
old, 15.5 ug/dl,  as  a  second group under 4 years old, indicating that iron deficiency was not
a factor in the study.   At 35.2 ug/dl blood lead, 50 percent of the children  had significantly
elevated FEP  levels (2 standard deviations above the reference mean FEP).
     At blood  lead  levels  below 30-40 ug/dl,  any assessment of the EP-blood  lead relationship
is  strongly  influenced by the  relative  analytical  proficiency of measurements  of  both blood
lead and EP.   The  types of statistical analyses used are also important.  In  a recent  detailed
statistical study  involving 2004  children, 1852 of whom had blood lead values below 30 ug/dl,
segmental  line and probit  analysis techniques  were employed  to  assess the dose-effect thres-
hold and  dose-response relationship.   An  average blood  lead threshold  for  the effect using
both statistical  techniques was 16.5 ug/dl for  the  full  group  and  for  those  subjects  with
blood  lead below  30  (jg/dl•   The effect of iron deficiency was tested for and was removed.   Of
particular interest was the finding that blood  lead values of 28.6 and 35.2 ug/dl corresponded
to  EP  elevations  of more than  1 or 2 standard deviations, respectively,  above  the reference
mean in 50 percent of the children.  Hence, fully  half of the children had  significant  ele-
vations of EP  at  blood lead levels around 30 ug/dl.   From various reports, children and adult
females appear to  be more sensitive  to  lead's  effects  on EP accumulation  at  any given blood
lead level; children are somewhat more sensitive than  adult females.
     Lead's effects on heme formation are not restricted to the erythropoietic system.  Recent
data indicate  that the  reduction  of serum  1,25-dihydroxyvitamin D  seen  with even low-level
lead exposure  is  apparently  the  result of  lead-induced inhibition of the  activity  of renal
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1-hydroxylase,  a cytochrome P-450  mediated  enzyme.   Moreover lead inhibits renal  ferrochela-
tase activity,  which,  with elevated  kidney EP,  leads  to a  reduction of heme available  for
heme-requiring  enzymes  such  as  renal 1-hydroxylase.   Reduction in  activity  of the  hepatic
enzyme tryptophan  pyrrolase and concomitant increases  in plasma tryptophan as well as  brain
tryptophan,  serotonin,  and  hydroxyindoleacetic acid have  been shown  to  be associated with
lead-induced reduction  of the hepatic  heme pool.   The heme-contaim'ng hepatic protein  cyto-
chrome P-450 (an  integral  part of the hepatic mixed-function oxygenase system)  is affected in
humans and animals by  lead exposure, especially  acute  intoxication.  Reduced  P-450  content
correlates  with impaired activity  of detoxifying enzyme systems such  as  aniline hydroxylase
and  aminopyrine demethylase.   It is also responsible for reduced 6p-hydroxylation of cortisol
in children having moderate lead exposure.
     Studies of organotypic chick and mouse dorsal root ganglion in culture show that the ner-
vous system has heme  biosynthetic capability and  that  not only is this capability reduced in
the  presence of  lead  but production  of porphyrinic material  is increased.   In  the neonatal
rat, depending  on the age at dosing and the duration of  dosing, chronic lead exposure result-
ing  in moderately  elevated blood lead is associated with  retarded increases in the hemoprotein
cytochromes  and with disturbed  electron transport in  the  developing cerebral  cortex.  These
data parallel  effects of lead on  ALA-D  activity and ALA accumulation  in neural tissue.  When
both of  these effects are  viewed  in  the toxicokinetic context  of increased retention of lead
in   both  developing  animals  and  children, there  is  an obvious and serious  potential  for
impaired  heme-based metabolic  function in the nervous system  of lead-exposed children.
     As  can be concluded from the  above discussion,  the health significance of ZPP accumula-
tion rests with  the  fact  that  it is evidence  of  impaired  heme and hemoprotein formation  in
many tissues  that arises  from  entry of  lead into mitochondria.   Elevation  of EP in children  at
relatively low blood  lead levels  is  considered by the  pediatric medicine community to be a
matter  of concern, and the  Centers for  Disease Control in their recent statement on lead  poi-
soning  in children (U.S.  Centers for  Disease Control, 1985)  have noted that a blood  lead level
above  25 ug/dl along with  an  EP level  above 35 ug/dl whole blood is to be taken  as  early  evi-
dence  of  lead  toxicity.   Such  evidence  for reduced heme synthesis  is consistent with a great
deal of data documenting  lead-associated effects on mitochondria.    The relative  value of the
 lead-ZPP  relationship  in  erythropoietic tissue as an  index of this effect in  other tissues
 hinges  on the relative  sensitivity  of  the  erythropoietic  system  compared  with other organ
 systems.    One  study  of  rats  exposed over their  lifetime to  low levels  of  lead demonstrated
 that protoporphyrin  accumulation in  renal tissue was  already significant at levels  of  lead
 exposure which produced little change in erythrocyte porphyrin levels.
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     Other  steps  in the heme biosynthesis pathway  are  also  known to be affected by lead,  al-
though  these  have not been as well studied on a biochemical  or molecular level.   Coproporphy-
rin levels  are increased in urine, reflecting active lead intoxication.   Lead also affects  the
activity of the enzyme uroporphyrinogen-I-synthetase in experimental  animal  systems, resulting
in  an  accumulation of  its substrate,  porphobilinogen.   The erythrocyte enzyme  has  been  re-
ported  to  be  much more sensitive to  lead  than  the hepatic species,  presumably accounting  for
much of the  accumulated  substrate.   Unlike the case with experimental  animals,  lead-exposed
humans  show no  rise in urinary porphobilinogen, which  is  a  differentiating characteristic of
lead  intoxication  versus  the hepatic  porphyrias.   Ferrochelatase  is  an  intramitochondrial
enzyme,  and  impairment  of its activity  either directly  by lead or  via  impairment of  iron
transport to the enzyme is evidence of the presence of lead in mitochondria.
12.3.6.2   Lead Effects on  Erythropoiesis and Erythrocyte Physiology.    Anemia is  a  manifesta-
tion of  chronic  lead  intoxication and is characterized as mildly hypochromic and usually nor-
mocytic.   It  is  associated with  reticulocytosis,   owing  to  shortened cell  survival, and  the
variable presence of basophilic stippling.   Its  occurrence is due to  both decreased production
and increased rate  of destruction of erythrocytes.  In young children (<4 yr old),  iron defi-
ciency anemia is  exacerbated  by  lead uptake, and  vice  versa.   Hemoglobin production is nega-
tively  correlated  with blood  lead  in young children,  in  whom iron  deficiency may be  a  con-
founding  factor,  as  well  as  in lead  workers.    In  one  study, blood  lead  values that were
usually below 80  (jg/dl  were  inversely correlated  with  hemoglobin  content.   In these subjects
no  iron  deficiency was  found.   The  blood  lead threshold for  reduced  hemoglobin  content is
about 50 pg/dl in adult lead workers and somewhat lower (about 40 ug/dl) in children.
     The mechanism of lead-associated anemia appears to be a  combination of reduced hemoglobin
production  and  shortened erythrocyte survival  due to direct cell injury.   Lead's  effects on
hemoglobin production  involve  disturbances  of  both heme and  globin biosynthesis.   The hemoly-
tic component to  lead-induced  anemia appears to be caused by increased cell  fragility and  in-
creased osmotic resistance.   In  one study using rats, the hemolysis  associated with vitamin E
deficiency, via reduced  cell  deformability,  was exacerbated by  lead  exposure.   The molecular
basis  for  increased cell  destruction rests with  inhibition of (Na  ,  K )-ATPase and pyrimi-
dine-5'-nucleotidase.   Inhibition of  the  former enzyme leads to cell  "shrinkage" and inhibi-
tion of the latter results in impaired pyrimidine nucleotide  phosphorolysis  and disturbance of
the activity of the purine nucleotides necessary for cellular energetics.
12.3.6.3  Effects of lead on erythropoietic pyrimidine metabolism.  In  lead  intoxication,  the
presence of both  basophilic  stippling and anemia with a hemolytic component is due to inhibi-
tion by  lead  of  the activity of pyrimidine-5'-nucleotidase  (Py-5-N),  an enzyme that mediates
the dephosphorylation  of pyrimidine  nucleotides  in the maturing  erythrocyte.   Inhibition of

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this enzyme by lead has been documented in lead workers,  lead-exposed children,  and experimen-
tal animal  models.   In one study of  lead-exposed  children,  there was a  negative  correlation
between blood  lead and enzyme  activity,  with  no  clear response threshold. A  related  report
noted that, in addition, there was a positive correlation between cytidine phosphate and blood
lead and an inverse correlation between pyrimidine  nucleotide and enzyme  activity.
     The metabolic significance  of  Py-5-N inhibition and cell nucleotide accumulation is that
they affect erythrocyte stability and survival as  well as potentially affect mRNA and protein
synthesis  related  to globin chain  synthesis.   Based on one  study of  children,  the threshold
for the inhibition of Py-5-N activity appears to be about 10 ug/dl blood lead.   Lead's inhibi-
tion of Py-5-N activity and a threshold  for such  inhibition are not by themselves the issue.
Rather, the issue is the  relationship  of such inhibition to a  significant level  of impaired
pyrimidine  nucleotide  metabolism and the consequences for erythrocyte stability and function.
The  relationship  of  Py-5-N  activity  inhibition  by  lead  to accumulation  of  its pyrimidine
nucleotide  substrate  is analogous to lead's  inhibition  of ALA-D activity  and accumulation of
ALA.
12.3.6.4   Effects  of Alkyl  Lead  Compounds on  Heme Biosynthesis and Erythropoiesis.  Tetraethyl
lead  and  tetramethyl  lead, components of leaded gasoline,  undergo  transformation iji vivo to
neurotoxic  trialkyl  metabolites as well  as  further  conversion to inorganic lead.  Hence, one
might  anticipate that exposure  to  such agents may result in effects  commonly  associated with
inorganic  lead,  particularly in  terms  of heme synthesis and erythropoiesis.   Various  surveys
and case reports  show  that the habit of sniffing leaded  gasoline  is associated  with  chronic
lead  intoxication in  children  from  socially deprived  backgrounds  in rural or remote  areas.
Notable  in these  subjects is evidence of impaired  heme biosynthesis, as  indexed  by  signifi-
cantly reduced ALA-D activity.   In  several  case reports of  frank  lead  toxicity from habitual
 leaded gasoline  sniffing,  effects such  as  basophilic stippling in erythrocytes  and  signifi-
cantly reduced hemoglobin have also been  noted.
12.3.6.5   Relationships of Lead Effects on Heme Synthesis to Neurotoxicity.  The role of lead-
 associated disturbances of heme biosynthesis as a possible  factor  in neurological effects  of
 lead  is  of considerable  interest  due to the following:   (1)  similarities between  classical
 signs  of  lead neurotoxicity  and several neurological  components  of the  congenital  disorder
 acute  intermittent  porphyria;  and  (2)  some of the  unusual  aspects of  lead  neurotoxicity.
There  are  three  possible  points of connection between lead's effects on heme biosynthesis  and
 the nervous system.   Associated with both lead neurotoxicity and acute intermittent porphyria
 is the common feature of excessive  systemic accumulation  and  excretion of ALA.  In addition,
 lead  neurotoxicity  reflects,  to some degree, impaired  synthesis of heme  and hemoproteins in-
 volved in  crucial cellular  functions; such  an  effect on  heme is  now  known to  be relevant
 within neural tissue as well as  in non-neural tissue.
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     Available  information indicates  that  ALA  levels  are  elevated in  the brains of  lead-
exposed animals and arise through in situ inhibition of brain ALA-D activity or through trans-
port  of  ALA to  the brain  after  formation  in other tissues.  ALA  is  known  to  traverse the
blood-brain  barrier.   Hence,  ALA  is accessible to,  or formed within,  the  brain  during lead
exposure and may express its neurotoxic potential.
     Based  on  various  ir\  vitro and j_n  vivo neurochemical studies of  lead  neurotoxicity,  it
appears  that ALA can  inhibit  release of the neurotransmitter  gamma-aminobutyric  acid (GABA)
from presynaptic  receptors  at  which ALA appears to  be  very  potent even at low levels.   In an
_in vitro study, agonist behavior by ALA was demonstrated at levels as low as 1.0 UM ALA.   This
HI  vitro  observation  supports  results of a  study  using lead-exposed rats in  which  there was
inhibition  of  both resting and K -stimulated release of preloaded 3H-GABA  from  nerve termi-
nals.  The  observation that iji vivo effects  of lead on  neurotransmitter function  cannot be
duplicated with  uj  vitro  preparations containing added  lead  is further evidence of an effect
of  some  agent (other  than  lead) that  acts  directly on this  function.  Human data on  lead-
induced associations between disturbed  heme  synthesis and neurotoxicity, while  limited,  also
suggest that ALA may function as a neurotoxicant.
     A number of  studies  strongly suggest that  lead-impaired  heme  production  itself may be a
factor in  the toxicant's  neurotoxicity.   In porphyric  rats treated also with phenobarbital,
both lead and the organic agent DDEP inhibit  tryptophan  pyrrolase activity owing to reductions
in  the hepatic  heme pool, thereby  leading to  elevated  levels of tryptophan and  serotonin in
the brain.   Such  elevations are known to induce  many of the  neurotoxic  effects also seen with
lead exposure.   Of great  interest  is the fact  that heme  infusion in these  animals  reduces
brain levels of  these  substances  and also restores enzyme activity and  the hepatic heme  pool.
It  remains  to be  demonstrated  that use  of  lead alone, without enzyme induction,  would show
similar effects.   Another line of  evidence  for  the  heme-basis of lead neurotoxicity  is that
mouse dorsal root  ganglion  in  culture manifests morphological  evidence of  neural  injury with
rather low  lead exposure,  but  such changes  are largely prevented with  co-administration of
heme.  Finally,  studies  also  show  that  heme-requiring cytochrome  C  production  is  impaired
along with operation of the cytochrome C respiratory chain in the brain when neonate rats are
exposed to lead.
12.3.6.6   Summary of Effects of Lead on Vitamin D Metabolism  There has recently  been  a  grow-
ing awareness of  the  interactions of lead and the  vitamin D-endocrine  system.   A recent  study
has found that  children with  blood lead levels  of 33-120  ug/dl showed  significant reductions
in  serum  levels  of  the  hormonal   metabolite   1,25-dihydroxyvitamin D  (1,25-(OH)2D).   This
inverse  dose-response  relationship  was  found  throughout the  range of  measured blood  lead
values,  12-120 ug/dl, and  appeared  to be the result  of  lead's effect on the production of the

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vitamin D hormone.  The  1,25-(OH)2D  levels  of children with blood  lead  levels of 33-55 (jg/dl
corresponded to the  levels  that have been observed in children with severe renal  dysfunction.
At  higher  blood  lead  levels  (>62 ug/dl), the  1,25-(OH)2D values were similar to  those that
have been measured  in  children with various inborn metabolic disorders.   Chelation therapy of
the  lead-poisoned children  (blood  lead  levels  >62  ug/dl)  resulted  in  a  return  to  normal
1,25-(OH)2D levels within a short period.
     In  addition  to its  well-known  actions  on  bone  remodeling  and  intestinal  absorption of
minerals, the vitamin D hormone has several other physiological actions at the cellular level.
These  include  cellular  calcium homeostasis  in  virtually all   mammalian  cells and associated
calcium-mediated  processes  that are essential for cellular  integrity and function.  In addi-
tion,  the  vitamin D hormone has newly recognized functions that  involve cell differentiation,
immunoregulatory  capacity, and  other roles distinct from  mineral  metabolism.  It  is reasonable
to  conclude,  therefore,  that  impaired  production  of  1,25-(OH)2D  can  have  profound  and
pervasive  effects  on  tissues  and cells of  diverse  type  and function  throughout the body.
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12.4  NEUROTOXIC EFFECTS OF LEAD
12.4.1  Introduction
     ^Historically, neurotoxic effects have long been recognized as being among the more  severe
consequences of human lead exposure (Tanquerel des Planches, 1839; Stewart,  1895;  Prendergast,
1910; Oliver, 1911; Blackfan, 1917).   Since the early 1900s, extensive research has focused on
the elucidation of lead exposure levels associated with the induction of various types of neu-
rotoxic effects and  related  issues,  such as critical exposure periods for their induction and
their persistence  or  reversibility.   Such research, spanning more than 50 years,  has provided
increasing evidence  indicating  that  progressively lower lead exposure  levels,  previously ac-
cepted as "safe,"  are actually sufficient to cause notable neurotoxic effects.
     The neurotoxic effects of extremely high exposures, resulting in blood lead levels  in ex-
cess  of  80-100 ug/dl, have been well  documented,  especially in regard to  increased risk for
fulminant lead  encephalopathy  (a  well-known clinical syndrome characterized by overt symptoms
such as gross ataxia, persistent vomiting, lethargy, stupor, convulsions,  and coma).  The per-
sistence of neurological sequelae in cases of non-fatal lead encephalopathy has also been well
established.   The  neurotoxic effects of subencephalopathic lead exposures  in both human  adults
and  children,  however,  continue to  represent  a  major area of  interest and controversy.   Re-
flecting this,  much  research  during the past 10-15 years has focused on  the  delineation of
exposure-effect relationships for  the following:   (1) the occurrence of overt signs and symp-
toms of neurotoxicity in relation to other indicators of subencephalopathic overt lead  intoxi-
cation; and  (2) the manifestation  of more  subtle,  often difficult-to-detect  indications  of
altered neurological  functions in  apparently asymptomatic  (i.e.,  not overtly lead-poisoned)
individuals.
     The present assessment critically reviews the available scientific literature on the neu-
rotoxic effects of lead,  first evaluating the results of human studies bearing on the  subject
and  then  examining pertinent animal  toxicology  studies.   The discussion of  human studies is
divided into  two   major  subsections  focusing on  neurotoxic effects of lead  exposure in (1)
adults and  (2) children.   Lead's  effects on both  the central  nervous  system (CNS) and the
peripheral nervous system (PNS) are discussed in each case.  In general, only relatively brief
overview summaries are provided  in  regard  to  findings bearing  on the  effects  of extremely
high-level exposures  resulting in  encephalopathy or  other  frank  signs  or symptoms of overt
lead  intoxication.   Studies  concerning the effects of lower-level lead exposures are assessed
in more detail, especially those dealing with non-overtly lead intoxicated children.   As for
the  animal  toxicology studies,  particular  emphasis  is  placed on  the  review  of  studies that
help  to  address certain important  issues  raised  by the human  research  findings,  rather than
attempting an  exhaustive review  of  all  animal  toxicology  studies  concerning the neurotoxic
effects of lead.
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12.4.2  Human Studies
     Defining  exposure-effect  or  dose-response  relationships  between   lead  and  particular
neurotoxic responses in humans  involves  two basic steps.  First,  there  must be  an assessment
of the  internal  lead burden resulting from external  doses of lead received via various  routes
of exposure (such as air,  water,  food, occupational  hazards,  house dust,  etc.).   Internal  lead
burdens may be  indexed  by lead concentrations in blood,  teeth,  or other tissue,  or by other
biological indicators.   The second step involves  an  assessment of the relationship of  internal
exposure indices to behavioral  or other types of  neurophysiological responses.  The difficulty
of this  task  is reflected by current  controversies  over existing data.   Studies vary greatly
in the  quality of  design,  precision  of  assessment  instruments,  care in  data  collection,  and
appropriateness of  statistical  analyses  employed.   Many of  these  methodological  problems  are
broadly common to research on toxic agents in general and not just to lead alone.
     Although epidemiological studies of lead's effects have immediate environmental relevance
at the  human  level,  difficult problems are often  associated with  the  interpretation  of the
findings,  as  noted in several  reviews  (Bornschein et al.  ,  1980;  Cowan and Leviton, 1980;
Rutter,  1980;  Valciukas  and  Lilis,  1980;  Needleman and  Landrigan,  1981).   The  main problems
are  the following:   (1)  inadequate  markers of exposure to  lead;  (2) insensitive measures of
performance;  (3) bias  in selection  of  subjects;  (4)  inadequate  handling of confounding co-
variates;  (5)  inappropriate statistical  analyses; (6)  inappropriate  generalization and inter-
pretation  of results;  and  (7)  the need for  "blind"  evaluations by experimenters and  techni-
cians.   Each of  these problems is  briefly  discussed  below.
      Each  major exposure  route—food,  water, air,  dust,  and soil—contributes  to a person's
• total  daily intake of  lead  (see  Chapters  7 and  11).   The relative  contribution of each expo-
sure route, however, is  difficult to ascertain;  neurotoxic  endpoint measurements, therefore,
are  most typically evaluated  in  relation  to one  or  another  indicator of overall  internal  lead
body burden.   Subjects in epidemiological  studies  may be misclassified as to  exposure  level
unless  careful choices of  exposure  indices are made based  upon the hypotheses   to be  tested,
the  accuracy and precision  of  the biological media assays,  and the collection  and assay  pro-
cedures employed.   Chapter 9 of  this document evaluates different  measures of  internal  expo-
 sure to lead and  their respective advantages and disadvantages.   The  most commonly  used  mea-
 sure of  internal  dose is  blood lead concentration, which  varies as a  function  of  age,  sex,
 race, geographic location,  and  exposure.   The blood lead level  is a useful marker of  current
 exposure but generally does not reflect cumulative  body lead burdens as well as  lead levels  in
 teeth.   Hair  lead  levels,  measured in some  human  studies,  are  not viewed as reliable  indica-
 tors of  internal   body burdens  at  this  time.   Future  research may identify a more standard
 exposure index, but it appears that a risk classification similar to that of the U.S.  Centers
 for  Disease  Control (1978) in  terms of blood lead and  free erythrocyte protoporphyrin (FEP)
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levels will continue in the foreseeable future to be the standard approach most often used for
lead exposure  screening  and  evaluation.   Much of the discussion  below  is, therefore,  focused
on  defining dose-effect  relationships  for human neurotoxic  effects in  terms  of blood  lead
levels; some ancillary information on pertinent tooth lead levels is also discussed.
     The frequency and  timing  of sampling for internal  lead  burdens represent another impor-
tant factor in evaluating studies  of  lead effects  on neurological  and  behavioral  functions.
For example, epidemiological studies  often rely on  blood lead and/or erythrocyte protoporphy-
rin (EP) levels determined at a single point in time to retrospectively  estimate or character-
ize internal exposure histories of study populations that may have been  exposed in the past to
higher levels  of  lead  than those indicated by a single  current blood sample.   Relatively few
prospective studies  exist that  provide  highly  reliable  estimates of critical  lead exposure
levels associated with  observed  neurotoxic effects  in human adults or children, especially in
regard to  the  effects  of subencephalopathic lead  exposures.   Some  prospective  longitudinal
studies on  the effects  of lead on early  development  of infants and young children are  cur-
rently  in   progress,  but  results  of  these  studies  are only  beginning to become  available
(see  Section   12.4.2.2.2.5 below).   The  present  assessment  of  the  neurotoxic effects  of
lead in humans must,  therefore,  rely most heavily  on  published epidemiological studies which
typically provide  exposure history  information  of  only  limited value  in defining  exposure-
effect relationships and less-than-optimum cross-sectional study designs.
     Key variables that  have emerged in determining effects of lead on  the nervous system in-
clude (1) duration and  intensity of exposure and (2) age at exposure.  Much evidence suggests
that young  organisms with  developing  nervous systems  are more  vulnerable than  adults  with
fully matured  nervous  systems.   Particular attention is, therefore, accorded below to discus-
sion of neurotoxic effects of lead in children as a  special  group at risk.
     Precision of measurement  is a critical  methodological  issue,  especially when research on
neurotoxicity leaves the  laboratory setting.  Neurotoxicity is often  measured  indirectly  with
psychometric or neurometric techniques  in epidemiological studies (Valciukas and Lilis, 1980).
The accuracy with  which these  tests reflect what they  purport to measure  (validity)  and the
degree to which they  are reproducible (reliability) are issues central  to the science of  mea-
surement theory.   Many cross-sectional  population  studies make  use of  instruments that are
only brief  samples of behavior  thought to be representative of some relatively constant under-
lying traits,  such  as  intelligence.  Standardization of tests  is  the subject of much research
in psychometrics.   The quality  and precision of specific test batteries  have been particularly
controversial  issues in evaluating possible effect levels for neurotoxic effects of lead expo-
sure in children.   Table 12A (Appendix 12A) lists some of the major tests used, together  with
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their advantages and weaknesses.   The  following review places most weight on results obtained
with age-normed, standardized psychometric test instruments,  and well-controlled,  standardized
nerve conduction velocity  tests.   Other measures, such as reaction  time,  finger  tapping,  and
certain  electrophysiological  measures  (e.g.,  cortical evoked  and slow-wave potentials)  are
potentially more sensitive indices, but are still experimental measures whose clinical utility
and psychometric properties  with  respect to the neurobehavioral toxicity of lead  remain to be
more fully explored.
     Selection  bias  is  a critical issue in epidemiological studies in which attempts are made
to  generalize  from  a  small  sample  to  a large population.   Volunteering  to participate in a
study  and attendance at special  clinics  or  schools are common forms  of  selection bias that
often limit how far  the  results of such  studies can  be generalized.  These factors may need to
be  balanced  in lead neurotoxicity research since reference groups are  often difficult to find
because  of the pervasiveness of  lead in the environment and  the many non-lead covariates that
also  affect performance.  Selection bias and  the   effects of  confounding  can be reduced by
choosing a more homogeneous  stratified  sample,  but the generalizability of the results of such
cohort studies  is  thereby  limited.
      Perhaps the greatest  methodological concern  in  epidemiological  studies  is controlling  for
confounding  covariates,  so that  residual  effects can be more  confidently attributed to lead.
Among adults,   the  most important covariates are age,  sex,  race,  educational level, exposure
history, alcohol  intake, total food intake, dietary calcium  and iron  intake, and urban  versus
rural  styles of living  (Valciukas and  Lilis, 1980).   Among children,  a  number of  developmental
covariates are additionally  important:   parental   socioeconomic  status   (Needleman  etal.,
1979);   maternal IQ  (Perino  and  Ernhart,  1974); pica (Barltrop,  1966); quality  of  the care-
giving environment  (Hunt et al.,  1982;  Milar  et al., 1980); dietary  iron and calcium  intake;
vitamin  D levels; body  fat  and nutrition (Mahaffey  and Michaelson,  1980;  Mahaffey, 1981);  and
age at exposure.   Preschool  children below the age  of 3-5 years appear to be particularly  vul-
nerable,  in that  the  rate of accumulation of  even  a low body lead burden  is  higher for  them
than for  adults  (National  Academy  of  Sciences, Committee  on Lead in the  Human Environment,
 1980).   Potential  confounding  effects  of  covariates become  particularly important when trying
 to interpret threshold effects of lead exposure.  Each covariate alone may not be significant,
 but, when combined, may  interact to  pose a  cumulative  risk which could result in under- or
 overestimation of a small effect of lead.
      Statistical  considerations  important not only  to lead but to all epidemiological  studies
 include  adequate  sample size  (Hill, 1966),  the use of multiple  regression (Cohen and Cohen,
 1975),  and the use  of multivariate  analyses (Cooley and Lohnes, 1971).  Regarding sample size,
 false negative conclusions  are at  times  drawn from small studies with low statistical power.
 It is often difficult and expensive to  use large sample sizes  in  complex  research such  as that
                                             12-55

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 on  lead neurotoxicity.   This fact makes  it all the more important to use sensitive assessment
 instruments  which have  a high  level  of  discriminating power and can be combined into factors
 for  multivariate analysis.   Multiple statistical comparisons can then  be  made while reducing
 the  likelihood of finding a certain  number  of significant differences by chance alone.   This
 is a serious  problem, because near-threshold effects are often small and variable.
      A  final  crucial  issue in this and other research  revolves around the care taken to assure
 that investigators are  isolated from information  that might identify  subjects in  terms  of
 their lead exposure levels at  the time of assessment  and data recording.   Unconscious biases,
 nonrandom  errors, and arbitrary  data correction and exclusion can be ruled out only if a study
 is performed  under blind conditions or, preferably, double-blind conditions.
      With  the above  methodological  considerations  in  mind,  the following  sections  evaluate
 pertinent  human  studies.  The  discussion includes  an overview of  lead  exposure  effects  in
 adults,  followed by  a  more  detailed  assessment  of neurotoxic  effects  of  lead  exposures  in
 children.
 12.4.2.1   Neurotoxic Effects of  Lead Exposure in Adults.
 12.4.2.1.1  Overt lead intoxication in adults.   Severe neurotoxic effects  of extreme exposures
 to  high levels  of  lead,  especially  for  prolonged  periods that produce overt  signs  of  acute
 lead  intoxication,  are  well  documented in regard to  both  adults and children.   The most pro-
 found (CNS) effects in adults have been referred to for many years  as the  clinical syndrome  of
 lead  encephalopathy,  described   in detail  by Aub et al. (1926),  Cantarow and Trumper (1944),
 Cumings  (1959),  and Teisinger and Styblova  (1961).   Early features of the  syndrome  that may
 develop  within weeks  of  initial exposure include dullness,  restlessness,  irritability,  poor
 attention  span,  headaches, muscular  tremor,  hallucinations, and loss of memory.   These  symp-
 toms  may progress to  delirium,  mania, convulsions, paralysis, coma,  and  death.   The onset  of
 such  symptoms can often be quite abrupt,  with convulsions,  coma,  and even  death  occurring very
 rapidly  in patients who shortly before appeared to exhibit much  less severe or  no symptoms  of
acute lead intoxication  (Cumings,  1959;  Smith  et al., 1938).   Symptoms of  lead  encephalopathy
 indicative of  severe  CNS  damage and posing a  threat  to life are generally  not  seen in adults
except at blood lead levels well in excess of 120 ug/dl (Kehoe,  1961a,b,c).   Other data (Smith
et al., 1938) suggest that acute lead intoxication,  including severe gastrointestinal  symptoms
and/or signs of encephalopathy can occur in some adults at  blood  lead levels  around 100 ug/dl
but ambiguities make the data difficult to interpret.
      In addition to the above CNS effects, lead also clearly damages peripheral  nerves at tox-
ic,   high-exposure levels  that predominantly  affect large myelinated nerve fibers (Vasilescu,
1973; Feldman et al.,  1977; Englert,  1980).  Pathologic changes  in peripheral nerves,  as  shown
in animal studies, can include both segmental demyelination and,  in  some fibers,  axonal degen-
eration  (Fullerton,  1966).   The former types  of  changes appear  to  reflect  lead's  effects  on
                                           12-56

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Schwann  cells,  with  concomitant  endoneurial  edema  and  disruption  of  myelin  membranes
(VMndebank and Dyck,  1981).   Apparently,  lead induces a  breakdown  in the blood-nerve barrier
which  allows  lead-rich edema  fluid to enter the endoneurium  (Dyck etal.,  1980;  Windebank
etal.,  1980).    Remye 11 nation observed  in  animal  studies  suggests either  that such  lead
effects  may  be reversible  or that  not  all  Schwann  cells are  affected  equally  (Lampert and
Schochet, 1968; Ohnishi  and Dyck, 1981).   Reports of plantar arch deformities due to old per-
ipheral  neuropathies  (Emmerson,  1968),   however,  suggest  that  lead-induced  neuropathies  of
sufficient severity  in human adults could  result  in  permanent peripheral nerve damage.   Mor-
phologically, peripheral  neuropathies  are usually detectable only  after  prolonged high  expo-
sure  to lead, with  distinctly different sensitivities  and histological  differences existing
among  mammalian  species.   In  regard to man,  as an example,  Buchthal  and Behse (1979, 1981),
using  nerve  biopsies from a worker with  frank lead neuropathy  (blood  lead = 150 ug/dl),  found
histological  changes  indicative of axonal degeneration in association  with reductions in nerve
conduction  velocities that  corresponded  to  loss  of large  fibers  and decreased amplitude of
sensory potentials.
      Data  from numerous studies provide  a  basis by which to estimate lead exposure  levels at
which adults  exhibit overt  signs or symptoms of neurotoxicity  and  to compare  such  levels with
those associated  with other types  of  signs and  symptoms  indicative of overt  lead  intoxication
(Sakurai et  al.,  1974; Lilis  etal.,  1977;   Tola and Nordman,  1977; Irwig  etal.,  1978a,b;
Dahlgren,  1978;   Baker etal., 1979;  Haenninen  etal.,  1979;  Spivey etal.,  1979;  Fischbein
et al., 1980; Hammond et al., 1980; Kirkby  et  al.,  1983).   These studies evaluated  rates of
various clinical  signs and symptoms  of lead intoxication across a wide range  of lead exposures
among occupationally exposed smelter and  battery plant workers.
      Considerable individual  biological  variability  is  apparent  among  various  study popula-
tions and individual  workers  in  terms of observed lead levels associated with overt signs and
 symptoms of  lead intoxication, based  on  comparisons of exposure-effect and dose-response data
 from  the  available  studies.   For  example,   Irwig  et al.  (1978a,b)  and Zielhuis  and  Wibowo
 (1976) discuss data for black South African lead workers indicative of increased prevalence of
 neurological  symptoms  at  110  ug/dl  and gastrointestinal  symptoms  at blood lead levels  in ex-
 cess of 60 ug/dl.  Analogously, Hammond et al. (1980) reported significant increases in  neuro-
 logical (both CNS  and PNS) and gastrointestinal  symptoms among American smelter workers with
 blood  lead levels often exceeding 80 ug/dl, but not among workers whose exposure histories did
 not  include  levels above 80  ug/dl.   Also, Kirkby et al.  (1983)  found  no significant differ-
 ences  between 96 long-term lead smelter workers  and 96  matched control subjects in prevalence
 of self-reported symptoms of fatigue, headache,  nervousness,  sleep disturbance, constipation,
 or  colic.    Blood  lead levels for the  lead workers averaged 51 ug/dl  (range  13-91 ug/dl),
 whereas the  control group averaged  11 ug/dl  (range 6-16  ug/dl).
                                            12-57

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     In  contrast to  the above  results,  many  other  investigators  have reported  neurologic
symptoms and other overt signs and symptoms of lead toxicity at blood lead levels  ranging well
below  80 jjg/dl.   Lilis et  al.  (1977),  for  instance,  found that  CNS  symptoms  (tiredness,
sleeplessness,  irritability,  headaches)  were  reported by 55 percent and  muscle or  joint pain
by 39 percent  of a  group of  lead smelter  workers  whose blood lead  levels had never  been ob-
served  to exceed 80  ug/dl.   Low hemoglobin  levels  (<14 g/dl)  were found  in  more than  33
percent  of these workers.   In addition, Spivey et al.  (1979) reported significantly increased
neurological   (mainly  CNS,  but  some  PNS)  symptoms and joint  pain  among a  group  of 69  lead
workers with mean ± standard deviation blood lead levels of  61.3 ± 12.8 ug/dl  in comparison to
a  control  group with  22.0 ±5.9  ug/dl  blood  lead values.  Haenninen et  al.  (1979)  similarly
reported significantly increased neurological  (both CNS and  PNS) and gastrointestinal  symptoms
among 25 lead workers with maximum observed blood lead levels of 50-69 ug/dl  and significantly
increased CNS  symptoms among 20  lower  exposure  workers with maximum blood  lead values  below
50 ug/dl.  Both groups were compared against a referent control group (N = 23) with  blood lead
values of 11.9 ±4.3 ug/dl.
     Additional  studies  (Baker et al.,  1979;  Fischbein et al.,  1980;  Zimmermann-Tansella et
al., 1983) provide  evidence  of  overt  signs  or  symptoms of  neurotoxicity occurring at lead
exposure  levels  still  lower  than those indicated above.   Baker et al.  (1979) studied  dose-
response  relationships  between clinical signs  and symptoms  of lead intoxication  among lead
workers  in two  smelters.   No overt toxicity was  observed at blood lead levels below 40 ug/dl.
However,  13  percent  of  those workers  with blood lead values in  the  range 40-79 ug/dl  had
extensor muscle weakness or gastrointestinal symptoms; and anemia occurred in 5 percent of the
workers with 40-59 ug/dl blood lead  levels, in 14 percent  with  levels  of 60-79 ug/dl, and in
36 percent with  blood lead  levels  exceeding 80 ug/dl.   Also, Fischbein et al.  (1980),  in  a
study of 90  cable splicers  intermittently exposed to  lead,  found higher zinc protoporphyrin
levels (an indicator  of  impaired  heme synthesis associated with  lead exposure) among workers
reporting CNS  or gastrointestinal  symptoms than  among other cable splicers not  reporting such
symptoms.  Only  5 percent  of these workers had  blood  lead  levels in excess of 40  ug/dl,  and
the mean  ± standard  deviation blood lead  levels  for  the 26 reporting CNS symptoms were 28.4
±7.6  ug/dl  and  30 ± 9.4  ug/dl  for  the  19  reporting gastrointestinal symptoms.   However,
caution  must  be exercised in  accepting  these  latter  blood  levels as being  representative of
average  or maximum  lead  exposures of this  worker  population,  in  view of the highly intermit-
tent nature  of their  exposure and the  likelihood of  much higher peaks in their  blood lead
levels than those coincidentally measured at the  time  of their blood sampling.
     Lastly,  Zimmermann-Tansella  et al.  (1983)  have  independently confirmed and extended pre-
viously  described findings  of Haenninen  et  al.  (1979).   Three  groups  of  20  men each  were
matched on age, education,  marital status,  chronic illnesses,  personality characteristics, and
                                            12-58

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length of employment.   The control  group had no history of occupational  exposure  to  lead  (mean
blood lead level =  20.4  ± 6 H9/dl).   The lead-exposed groups were composed of workers  from  an
electric storage  battery plant, with  the low-lead  group averaging 31.7 ±2.9  ug/dl  (range:
26-35 Mg/dl)  and tne  high-lead  group 52.5 ±  5.1  ug/dl  (range:  45-60 ug/dl).   None ever ex-
ceeded 60 ug/dl.   In  conjunction with other psychological testing (Campara et al.,  1984), two
questionnaires were given  that  asked about a  variety  of  emotional,  neurological,  and  gastro-
intestinal symptoms similar  to  symptoms covered by the questionnaire used by Haenninen et al.
(1979).   The most  clear-cut effects,  in terms of  significant and  consistent  dose-response
trends, were found in physical symptoms (such as loss of appetite, paresthesis in lower limbs,
weakness of upper limbs, and dropping of objects) with the most marked increases seen in rates
of  neurological  symptoms  in  the high-lead  group.   Coupled with  the  increased  symptom rates
observed  by  Zimmermann-Tansella et  al.  (1983) were observations reported  by Campara et  al.
(1984)  indicating  that  the  high-lead workers  did significantly more poorly  on a  variety  of
psychometric tests  (e.g.,  the WAIS), with general performance  (on cognitive  and visual-motor
coordination  tasks)  and verbal  reasoning ability  most  markedly  impaired.   These findings,
consistent with  earlier results of  Haenninen  et al.  (1978,  1979), indicate that overt neurol-
ogical  symptoms  and impaired CMS functioning,  as  well as gastrointestinal  symptoms,  occur in
adults  at blood  lead  levels  of 45-60 ug/dl.
      Overall,  the results  reviewed  above appear  to support the following conclusions:  (1)
overt signs  and symptoms  of  neurotoxicity in  adults are  manifested  at  roughly comparable lead
exposure levels  as other  types  of overt signs and symptoms  of  lead  intoxication, such as gas-
trointestinal  complaints;  (2) neurological signs  and  symptoms  are indicative of both central
and peripheral  nervous  system effects;  (3) such  overt signs and symptoms,  both neurological
and otherwise, occur at markedly  lower blood  lead levels than  levels previously thought to be
"safe"  for adults; and  (4)  lowest observed effect levels for the neurological signs and symp-
toms in adults  can most credibly be stated to be in the 40-60 ug/dl range.   Insufficient  in-
formation currently  exists  to  estimate  with  confidence  to what extent or for how long such
overt signs  and symptoms persist in  adults after termination of precipitating external lead
 exposures,  but  at  least one study  (Dahlgren,  1978)  has  reported abdominal pain persisting as
 long as  29  months after  exposure termination among 15 smelter workers,  including four whose
 blood lead levels were between 40 and 60 ug/dl while working.
 12.4.2.1.2   Non-overt lead intoxication in adults.    Of   special  importance  for  establishing
 standards for exposure to lead is the question of whether exposures lower than those producing
 overt  signs  or symptoms  of lead intoxication  result in less obvious  neurotoxic effects in
 otherwise apparently  healthy individuals.  Attention has focused in particular on whether ex-
 posures  leading to  blood lead levels  below  80-100 ug/dl  may  lead  to behavioral  deficits or
 other neurotoxic effects  in  the absence of classical  signs  of overt  lead  intoxication.
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     In adults,  one  might  expect neurobehavioral deficits to be reflected by performance mea-
sures  in  the workplace, such as  higher  rates  of absences or reduced  psychomotor  performance
among  occupationally exposed  lead workers.  Some  epidemiological  studies  have  investigated
possible relationships between elevated blood lead and general  health as indexed by records  of
sick absences  certified by  physicians  (Araki  et al.,  1982;  Robinson, 1976;  Shannon  et al.,
1976; Tola  and  Nordman,  1977).   However, sickness  absence rates  are generally poor epidemio-
logic  outcome measures  that may be confounded by many variables and are difficult  to  relate
specifically  to lead  exposure   levels.   Much  more useful  are  studies that  evaluate  direct
measurements  of central  or  peripheral  neurological functions  in relation  to  lead  exposure.
     A number of studies have employed sensitive  neurological  and/or psychometric testing pro-
cedures in  an effort to demonstrate specific lead-induced neurobehavioral  effects  in  adults.
Disturbances  in oculomotor function have been found in two studies of lead-exposed workers.
The  first,  a  prospective  investigation  by Baloh et al.  (1979),  found significantly decreased
saccade accuracy and  similar but  nonsignificant  differences  in  saccade velocity  and  delay
times in lead workers (mean blood lead:  ~61  ug/dl) compared to  controls.  A follow-up examina-
tion  (Spivey  et  al.,  1980)  essentially replicated the  original   findings.   A more  recent
investigation of saccadic  eye movements  by  Glickman et  al.  (1984)  also found highly signifi-
cant decreases  in  saccade  accuracy and increases in overshoots  among lead workers  (mean blood
lead: 57 ug/dl), particularly younger workers.   The difference in  saccade  velocity  fell just
short of statistical  significance  overall  (p = 0.056),  but was  highly significant (p  <0.004)
in the  20-29 year age  group.  Also,  velocity  and  ZPP were significantly  correlated  overall
(r = -0.40, p <0.005).
     Morgan and Repko  (1974)  reported deficits  in  hand-eye coordination  and reaction  time  in
an extensive  study of  behavioral  functions  in  190 lead-exposed  workers (mean blood lead level
= 60.5 ±  17.0 ug/dl).   The majority of  the  subjects had been  exposed between 5 and 20 years.
In a similar study,  however, Milburn et al.  (1976) found no differences between  control  and
lead-exposed workers  on numerous psychometric and other performance tests.  On the  other hand,
several other  studies (Arnvig et  al.,  1980;  Grandjean et al.,  1978;  Haenninen  et al.,  1978;
Hogstedt et al.,  1983;  Mantere  et al.,  1982; Valciukas  et al.,  1978)  have found disturbances
in reaction  time,  visual  motor  performance, hand  dexterity,  IQ test/cognitive  performance,
mood, nervousness, or  coping in  lead workers with blood lead levels of 50-80 ug/dl.  Hogstedt
et al.  (1983)  also  found  impaired  memory and  learning ability in  workers  with  time-weighted
average blood lead levels of 27-52 ug/dl.  Furthermore, Baker et al. (1983) found significant-
ly increased  rates  of depression,  confusion, anger, fatigue,  and  tension  among workers with
blood lead levels above 40 ug/dl, who did not differ from referent control workers  in terms  of
reported  incidence  of abdominal  colic  or other  gastrointestinal symptoms  characteristic  of
overt  lead  intoxication.   Other  aspects  of  neurobehavioral function in the same workers were
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also found to  be  impaired,  including verbal concept formation,  memory,  and visual/motor per-
formance.   A  graded  dose-effect  relationship  for non-overt  CMS  lead  effects  in  otherwise
asymptomatic adults is indicated by such studies.
     In addition  to  the  above studies indicative of psychoneural  dysfunctions  in non-overtly
lead  intoxicated  adults, numerous  investigations  have examined peripheral  nerve function  by
measuring the  conduction velocity  of electrically stimulated nerves in the arm or leg.   Nerve
conduction  velocity  (NCV)   provides  a  readily accessible  indication  of  neurophysiological
function  in sensory  as well as motor nerves.  However, nerve temperature (and to some extent,
skin  temperature  and  room  temperature),  age,  and limb length  affect  conduction velocity and
thus  may confound  NCV  measurements.   Table  12-1 summarizes  several  studies   of  groups  of
lead-exposed  subjects and  notes what was  done to deal  with  the  above confounding factors.
     Of  particular note are the positive  findings  of  decreased NCVs  at blood  lead levels  of
30-50  |jg/dl  from  a prospective occupational study by Seppalainen et al.  (1983)  in contrast to
the  negative  findings at blood lead  levels of 60-80  M9/dl from a  prospective study by  Spivey
et al.  (1980).  Also  contrasting are  the results of two cross-sectional  studies:  Rosen  et al.
(1983)  observed  significant slowing of NCVs as a function of  average blood  lead levels moni-
tored  over  9  years,  whereas  Triebig  et al. (1984) reported no  apparent dose-effect relation-
ship on NCVs  except  at  blood lead levels exceeding 70 ug/dl.   Although Triebig et  al.  (1984)
did  not examine as many neurophysiological  variables  as  Rosen et  al.  (1983), they  did  incor-
porate many more  lead-exposed subjects  (N  = 133)  compared to most  occupational  lead  studies of
NCV.   Triebig et al.  (1984)  also  noted that the  earlier  findings  of Seppalainen et  al.  (1975,
1979)  were confounded by age effects, since  their lead-exposed subjects were  older than  the
controls, but  no correction  was  made for  the normal  slowing of NCV with increasing age.
However,  even if one allows -a decline of  approximately  2  m/sec in NCV for each 10 years'  in-
crease in age (based on  Triebig  et  al.,  1984), the  age differences  in  Seppalainen  et  al.
 (1983) would not appear to be sufficient  to  account  for the  significant declines  in  NCV that
 they  found,  except  possibly  at  the four-year stage  of their  longitudinal  study.   Moreover,
 Rosen et al.   (1983)  did include age as a covariate  in their  analyses  and still found signi-
 ficant effects of lead on NCV and  other neurophysiological variables.
      One difficulty  in drawing conclusions from the  studies presented in  Table  12-1  is  the
 lack of consistency among studies, either in the nerves examined or in the significance of  re-
 sults obtained.  No  one nerve has been consistently used in all the  studies dealing with lead
 exposure and NCV measurements.  Even when a particular nerve is singled out for  consideration,
 the  results  may  not  be  in  complete  agreement.  For example,   Seppalainen  et al. (1975, 1979)
 initially found  the  ulnar slow fiber NCVs  to  be a sensitive indicator  of  lead-induced  impair-
 ment.  But more  recent work  by Seppalainen et al.  (1983) and some other  investigators  (e.g.,

                                             12-61

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                                        TABLE  12-1.   SUMMARY OF STUDIES ON NERVE CONDUCTION VELOCITY IN GROUPS OF LEAD-EXPOSED SUBJECTS
CTi
ro
Mean blood lead,
ug/dl
Reference
Seppatainen
et al. (1983)














Corsi et al.
(1984)



Johnson et al.
(1980)


Seppala'inen
et al. (1979)






Exp. Con.
(range/±S.D.)
16
(7-30)


31
(13-48)


30
(13-48)


27
(17-37)


28
(•ax: 71-
180 4 yr
or more
earlier)
9 30(±14)

* 56(113)

34 actual
45 THAT
(•ax: <70)





10
(1-21)


10
(7-18)


10
(5-21)


7
(4-12)


20




10(±4)

15(±6)

10







Exposure No. of
period, yr. subjects
(range/lS. D. ) Exp. Con.
0 23 23



1 23 23



2 15 15



4 10 10



7 38 23
(0.08-37)
(3-27 yr
since last
exposure)
2.4(±1.5) 45 31

12.4(±10) 164 108

~8 61 34







NCV,
m/sec %
Nerve*
Med
Med
Uln
Uln
Med
Hed
Uln
Uln
Hed
Hed
Uln
Uln
Hed
Hed
Uln
Uln
Uln
\i\n
Per
Per

Uln
Per
Uln
Per
Hed
Hed
Uln
Uln
Uln
Per
Tib
Sur
- n
- s
- •
- s
- •
- s
- •
- s
- n
- s
- m
- s
- n
- s
- M
- S
- m
- sf
- m
- sf

- a
- m
- m
- m
- m
- s
- n
- s
- sf
- n
- m
- s
Exp.
58.8
63.7
60.7
62,1
55.7
60.5
57.0
59.2
54.8
58.5
59.3
59.9
59.1
59.9
62.8
63.2
54.5
49.9
48.7
45.2

58. 8
52.3
56.5
49.4
59.6
62.0
60.7
60.9
42.5
54.6
48.6
43.9
Con.
60.7
64.2
59.3
62.7
61.5
64.2
61.5
64.6
60.4
60.7
62.2
60.8
64.5
61.1
62.9
66.1
57.9
54.0
51.3
48.5

61.5
55.2
57.1
50.4
61.0
65.3
60.5
63.1
45.9
54.3
50.7
43.9
Diff.
-3
-1
+2
-1
-9
-6
-7
-8
-9
-4
-5
-2
-8
-2
0
-4
-6
-8
-5
-7

-4
-5
-1
-2
-2
-5
0
-4
-7
+1
-4
0
P
N.S.
N.S.
N.S.
N.S.
<0.01
<0.05
<0.01
<0.01

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                                                                               TABLE 12-1.  (continued)
ro
 i
Mean blood lead,
ug/dl

Reference
Seppalainen
et al. (1975)






Verberk (1976)

Exp.
(range/±S
40
Con.
.0.)
10-13
(28-65) (estimated)






40







20

Exposure
period, yr.
(range/±S.D. )
4.6
(1-17)





Overal 1
49 days

No
. of
NCV,
subjects
Exp.
26
25
26
26
25
25
26
= 26
10

Con.
26
8
26
22
23
26
19
= 26
9

Nerve*
Hed - m
Hed - s
Uln - m
Uln - sf
Uln - s
Per - m
Tib - m

Uln - n
Uln - sf
IT/ sec %
Exp.
54.5
59.5
55.0
42.0
58.2
50.6
43.4

57.4
46.2
Con.
58.5
56.3
58.1
47.1
60.0
52.0
44.6

59.2
50.8
Diff.
-7
+6
-5
-11
-3
-3
-3

-3
-9
P
<0.005
N.S.
<0.01
<0.001
N.S.
N.S.
N.S.

N.S.
N.S.
Comments
Con. group values ob-
tained from separate
studies.





Volunteers ingested Pb. No
info, on skin temperature
       Rosen et al.
         (1983)
       Bordo et al.
         (19B2a,b)
       Araki & Honma
         (1976)
     >40        <25
 («ax: >55)  (max: 30)
               (0.5-28)
  42(112)
 (avg. <50
during preced-
 ing 24 no.)

      45
   (29-73)
16(t3)
                                         12
    4
(O.b-10)
                  18
               (0.67-46)
15
16
(intermediate
PbB
N



62


group
= 8)



27


Uln
Hed
Fib
Tib
Uln
Hed
Sur
Hed
Hed
Per
- m
- m
- m
- m
- sf
- s
- s
- m
- s
- m
57
55
45.
44
40.
48.
43.
59.
59.
51.
.0
.8
.7
.0
7
7
1
7
8
8
58.
56.
48.
45.
43.
48.
49.
63.
63.
51.
1
9
1
7
2
7
1
1
5
4
-2
-2
-5
-4
-6
0
-12
-5
-6
+1
N
N
0,
N.
N.
N.
D.
<0.
<0.
N.
.5.
.5.
,019
S.
S.
S.
022
01
01
S.
                                                                       19
                                                                                39
                                     Hed - m
                                     Hed - nx
                                     Tib - m
54.3
64.1
44.7
59.0
67.1
50.0
 -8
 -4
-11
<0.01
 N.S.
<0.01
                                                                                       or age comparisons. Resi-
                                                                                       dual error > difference be-
                                                                                       tween groups; ulnar-sf NCVs
                                                                                       12-13X faster in both
                                                                                       groups compared to pre-
                                                                                       exposure values.

                                                                                       NCV values adjusted for
                                                                                       age. Cumulative exposure
                                                                                       showed no apparent
                                                                                       effect.
                                    ANACOVA included age as
                                    covariate.  Duration of
                                    expos,  showed no effect.
Room temperature mea-
sured, but not skin
temperature.  No info.
on age of Con.  Ss.

-------
                                                                            TABLE  12-1.   (continued)
ro
en
Mean blood lead,
u9 89
62
86
Overall = 95

? 14


Con.
20
20
18
16
50

20
20
19
19
20

43
44
29
29
28
58



64




21
14
21
= 21

N/A


Nerve*
Uln
Uln
Rad
Rad


Uln
Uln
Rad
Rad


Med
Uln
Uln
Uln
Tib
Med
Uln
Uln

Med
Med
Sur
Tib

Med
Rad
Per


Med


- m
- sf
- m
- sf


- m
- sf
- m
- sf


- m
- m
- s
- sf
- m
- m
- m
- sf

- m
- s
- s
- m

- m
- m
- m


- m


NCV,
m/sec %
Exp.
55.2
48.5
62.1
41.7


52.4
45.1
65.2
51.3


53.4
55.6
56.4
48.0
50.5
55.0
55.2
34.3

54.7
46.7
44.2
47.2

56
67
48


52


Con.
55.7
49.4
65.2
51.2


53.6
48.7
68.0
49.7


59.9
64.5
63.0
45.7
55.5
55.1
56.1
33.2

61.3
45.7
44.9
49.6

56
64
48


58


om.
-1
-2
-5
-19


-2
-7
-4
+3


-11
-14
-10
+5
-9
0
-2
+3

-11
+2
-2
-5

0
+5
0


-11


P
N.S.
N.S.
N.S.
N.S.


N.S.
<0.05
N.S.
N.S.


0.00003
0.00003
0.015
N.S.
0.0013
N.S.
N.S.
N.S.

<0.0001
N.S.
N.S.
<0.025

N.S.
N.S.
N.S.


<0.01


Comments
Ulnar NCV values corrected
for skin temperature. Male
groups age-matched, female
Exp. group 3 yr older than
Con. group. Although com-
bined radial-sf values not
reported as statistically
significant, difference be-
tween female groups for
radial-sf NCVs appears to
be significant despite high
variance.
Skin temperature controlled
and corrected for data
analysis. Only sig. corre-
lation between PbB and NCV
was for ulnar-m.
Exp. group ~3 yr older than
Con. group. No info, on
skin temperature.

Con. values obtained from
separate independent study.
Room temperature and skin
impedance controlled, but
not skin temp.
Mean age of Exp. and
Con. groups equal, but
no info, on subsets of
Ss used in different
NCV tests.
Exp. Ss treated with EOTA
to reduce PbB; no sepa-
rate Con. group. Difference
                                                                                                                                               between Exp. and Con.
                                                                                                                                               values reflects change over
                                                                                                                                               1-mo to 3-yr period after
                                                                                                                                               EDTA treatment.

-------
                                                                          TABLE 12-1.  (continued)
no
 i
01
01
Reference
Paulev et al.
(1979)



Tri«big et al.
(1984)


Ashby (1980)









Singer et al.
(1983)





Spivey et al.
(1980)




Sborgia et al.
(1983)




Mean blood lead,
pg/dl Exposure No. of
Exp. Con. period, yr. subjects
(range/±S.D. ) (range/±S.O. ) Exp. Con.
53 11 12.9 mo 32 14
(±16) (±4) (2-37 mo)



53 actual <20 11 133 66
(22-90) (1-28)
54 TWA2

60 ? 0.5-33 94 94





58(±16) 24{±14) <2 13 13
-(man: <80)


60 ? 10.6 37 26
(±17) (0.5-28) 35 24
25 13
24 20
Overall = 4TJ 31


60 22 21 55 31
(±11.9) (±6.2)

66 28 1-1.5 yr later 55 31
(±12.5) (±8.4)

63 24 7.84 31 35
(i!9.0) (±7.4)




Nerve*
Uln -
Uln -



Uln -
Uln -
Uln -
Med -
Uln -
Med -
Rad -
Per -
Uln -

Uln -
Med -
Rad -
Per -
Med -
Hed -
Per -
Sur -



Uln -
Uln -
Per -
Uln -
Ulo -
Per -
Med -
Med -
Ked -
Med -
Uln -
Pop -
Tib -
n(lf>
m(rt)



m
s
s(d)
m
n
m
n
m
s

o
m
m
»
m
s
m
s



n
sf
m
in
sf
ra
m
sf
s(d)
s(p)
n
m
D
NCV,
m/sec %
Exp.
58.8
58.8



58.3
52.3
45.5
46.1
53.4
55.9
63.9
46.1
57.5

55.1
58.4
58.1
46.6
56.1
42.9
49.0
37.8



55.5
45.5
52.3
56.2
45.3
50. S
55.4
50.1
63.4
61.2
55.0
49.3
48.7
Con.
55.3
53.7



59. Z
53.1
47.5
47.1
55.6
57.3
71.7
47.6
57.9

58.0
59.8
74.1
49.9
57.6
46.8
49.2
42.8



56.0
46.9
51.5
53.1
44.1
48.9
56.6
49.7
62.7
61.0
54.5
50.0
46.4
Diff.
+6
+9



-2
+2
-4
-2
-4
-2
-11
-3
-1

-5
-2
-22
-7
-3
-8
0
-12



-1
-3
+2
+6
+3
+3
-2
+1
+1
0
+1
-1
+5
P
N.S.
N.S.



N.S.
N.S.
50.05
SO. 05
<0.0005
<0.01
<0. 0005
<0. 005
N.S.

<0.05
N.S.
<0.005
<0.05
0.36
0.006
0.87
.0.0004



M.S.
N.S.
N.S.
0.027
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
Comments
Room temperature con-
trolled; no info, on skin
temperature. Groups com-
parable in height, weight,
and age range.
Analysis of subgroup! ngs
of Exp. Ss by PbB indicated
that effects primarily
seen at £70 ug/dl.
Anomalous pos. correlation
observed between ulnar-ra
NCV and PbB; possibly
sig. due to use of multiple
t-tests. Skin temperature
of Con. Ss < Exp. Ss.
Separate analysis of
subset of Ss from main
study; linn ted to new
employees of <2'yr.
Adjustment of NCVs for
age and skin tenperature
increased statistical
significance of effects;
for Ss exposed >10 yr,
median-la NCV also sig-
nificantly slower.
Exp. group 2.8 yr
older than Con. group.
Sig. (<0.05) neg. corr.
between ulnar-n NCV
and age. Room and skin
temperature controlled.
NCVs corrected for skin
tenperature. Regression
analysis showed no sig.
effect of max. or past
avg. PbB, but cnax. ZPP
showed sig. association
with ulnar NCV.

-------
                                                                           TABLE 12-1.   (cDntinued)
cr,
cr.
Reference
Baker et al.
(1984)






Feldnan et al.
(1977)

Englert (1980)





Vasilescu (1973)



Melgaard et al.
(1976)




Catton et al.
(1970)


Buchthal A
Sense (1979)




Mean blood lead,
ua/dl
Exp. Con.
(range/±S.O. )
(60-80) (0-20)







70 ?
(ia-no)

71
(•ax: 140)




72 ?
(27-180)


78 -19
(38-125) (2-36)




(40-120+) ?



(70-14B) ?
(•ax.
during
preceding
year)

Exposure No. of
period, yr. subjects
(range/±S.D.) Exp. Con.
-2-3 5 20
(0-20) (intermediate
PbB groups
N = 92)




? 19 25


? 99 0





? 50 30



? 20 12





(0.4-13) 19 17



(0.33-33) 20 ?





Nerve*
Uln -
Uln -
Per -
Sur -




Per -


Uln -
Uln -




Med -
Uln -
Per -
Rad -
Per -
Uln -
Uln -



Pop -
Pop -


Med -
Med -
Per -
Sur -


m
s
m
s




m


m
sf




m
n
n
•
m
n
s



ID
S


„
S
m
s


NCV,
m/sec
Exp.
63.4
55.1
52.6
45.4




45.0


58.8
-47




55.6
56.6
46.1
44.8
48.7
55.0
-57.0



49.9
57.1


58.1
63.7
50.1
50.7


Con.
62.5
51.8
50.8
48.7




54.1


.
-




57.2
57.3
60.5
49.8
-50
-58
-54



49.6
56.3


63.6
67.1
51.0
54.6


%
Diff.
+1
+6
+4
-7




-17


_
-




-3
-1
-24
-10
-3
-5
+6



0
+1


-9
-5
-2
-7


P
N.S.
0.02
N.S.
0.03




<0.02


N.S.
N.S.




0.05
0.05
0.05
0.05
7
?
7



N.S.
N.S.


<0.001
<0.01
N.S.
<0.001


Contents
p-values refer to an
exposure coefficient
(based on 12-no TYft2)
in a multiple linear
regression Model allowing
for age, height, weight,
and skin temperature across
all PbB groups.
No info, on Con. Ss or on
ages of Exp. Ss. Skin
temperature not controlled.
Ho sig. correlation be-
tween NCV and PbB, but
sig. slowing at high ALA-U
levels. NCV corrected for
age, skin temperature,
and body height.
P values as reported. No
info, on skin temperature.
Exp. group about 2 yr
younger than Con. group.
Con. values estimated from
info, in report. MCVs
corrected for skin tempera-
ture but not age. Ss
exposed to other aetals
besides Pb.
Only sig. difference be-
tween groups was in ratio
of knee and ankle muscle
action potentials.
Ho histological evidence
of abnormality in sural
nerve. No info, on how
Con. values obtained,
but said to be matched
for age.
       *Med = median; Uln = ulnar; Per = peroneal; Tib = posterior tibial; Sur = sural; Fib - fibular; Pop = lateral popliteal;


        m = motor; s = sensory; nx = mixed; sf = slow fibers; If = left; rt = right; d = distal; p = proximal.


       tTVA = tine-weighted average.                *

-------
Rosen et  al.,  1983;  Spivey  et al., 1980)  has  failed  to find significant effects with  ulnar
slow fibers.  Nevertheless,  the  preponderance  of effects has been  in  the negative  direction,
as  reflected  in  the  column of  Table  12-1  showing  the percent  differences  in NCVs  between
lead-exposed and  referent groups.  Moreover,  of the  various nerves examined, the  most con-
sistently decreased NCVs  appear  to involve the median  motor  nerve.   Recent experimental work
with rats may  help  explain this finding.   Bouldin et  al.  (1985) found that lead-treated rats
showed a  greater  susceptibility  to demyelination in the sciatic nerve (a mixed nerve contain-
ing  a  large number of motor  fibers)  than in  the  sural nerve (a  sensory  nerve).   Given the
dependence  of  nerve conduction on the functional integrity of the nerve's myelin sheath, this
difference  in  susceptibility  would  help explain the  variability  in  results of NCV  studies
examining different types of nerves and is  consistent  with  the emergence of the median motor
nerve as  the most  prevalent  indicator  of  reduced  NCV  in  the studies  listed  in Table 12-1.
     A problem  inherent  in nearly all NCV  studies has been the lack of experimental manipula-
tion  of  the presumed cause  of lowered conduction velocities.  Of  interest  in  this  regard is
the  study of  Araki  et al.  (1980),  in  which median  motor NCVs were measured before and after
blood lead  levels were lowered through  chelation therapy.   The investigators found that, de-
pending  on  a  worker's  initial  NCV  and the  amount  of change  in  blood  lead  level achieved
through  chelation,  significantly  improved  nerve conduction  was  measured  in  7 of 14  lead-
exposed  workers.   For all  subjects considered together, the  increase  in NCV correlated sig-
nificantly  with the decrease in blood  lead  level  (r = -0.573, p <0.001).  The work of Araki et
al.  (1980), as well  as  case  studies  reported by Feldman et  al.  (1977), indicate  that  lead-
induced  impairment of  nerve conduction is reversible, at  least in part,  by a reduction in
blood  lead  levels through chelation therapy.   Although helpful  in establishing a causal con-
nection  between lead  exposure and  peripheral  nerve  function, these studies  have not resolved
the dispute over whether such effects merely  reflect  mild,  fully  reversible impacts of lead
(Buchthal and  Behse,  1981) or  are true early warning signals of progressively more  serious
neuropathy  in  otherwise  undiagnosed lead  intoxication  (Feldman et al.,  1977;  Seppalainen and
Hernberg, 1980).
      Taken  as  a  whole,   the  studies  reviewed  here  indicate  the  likelihood of NCV  effects at
blood lead  levels below  70  ug/dl,  possibly even as  low as  30 ug/dl,  although further prospec-
tive studies  are needed to characterize these levels  definitively.   It is  important  to note
that even  though many of  the observed changes  in NCV may fall  within the range of  normal
variation,  these studies  show significant  effects  in groups of  subjects,  not just  individual
 subjects.  Thus,  these  effects  clearly represent  departures  from normal  neurological  func-
 tioning and should be seriously considered for their potential  health significance.
                                            12-67

-------
 12.4.2.1.3   Other Hypothesized Neurotoxic Effects  of Lead in  Adults.   There are  several  case
 reports  of  previous overexposure to heavy metals, e.g. lead, in amyotrophic lateral sclerosis
 (ALS)  patients and patients dying  of  motor  neuron disease (MND).  These  reports  have  led to
 hypotheses  concerning the  relationship  between such  neurotoxic  syndromes  and  lead exposure
 Conradi  et  al.  (1976, 1978a,b, 1980), for example,  found elevated lead levels in the cerebro-
 spinal  fluid of  ALS  patients as  compared with controls.  In  addition,  Kurlander and  Patten
 (1979)  found that lead levels in  spinal  cord anterior horn cells of MND patients were  nearly
 three  times that of control subjects  and that lead  levels correlated with illness durations-
 despite  chelation therapy for about a year, high lead  levels remained in their tissue.   On the
 other  hand, certain other studies  (e.g., Manton and Cook, 1979; Stober et al.,  1983) have not
 found  evidence to support an  association of  lead  exposure with ALS.  Thus, the  evidence for
 possible  pathogenic  significance  of lead in  ALS and motor neuron disease is at best mixed at
 this time and the issue needs to be further explored by future research.
 12.4.2.2  Neurotoxic Effects of Lead Exposure in Children.
 12.4.2.2.1   Overt lead intoxication in children.   Symptoms  of encephalopathy similar to those
 that occur  in  adults have been reported  to occur  in infants and young children (Prendergast
 1910;  Oliver,  1911;   Blackfan,  1917;  McKhann and  Vogt,  1926;  Giannattasio  et al.,   1952-
 Cumings,  1959;  Tepper, 1963; Chisolm, 1968),  with a markedly higher incidence of  severe en-
 cephalopathic  symptoms and  deaths  occurring  among them than  in  adults.   This  may reflect the
 greater difficulty in recognizing early symptoms in young children,  thereby allowing intoxica-
 tion  to proceed  to a more  severe level  before  treatment is  initiated  (Lin-Fu, 1973).   jn
 regard to the  risk  of death in children,  the mortality rate for encephalopathy cases was ap-
 proximately  65 percent prior  to the  introduction of chelation  therapy  as standard medical
 practice (Greengard et al.,  1965;  National Academy of Sciences,  1972;  Niklowitz and Mandybur
 1975).    The following mortality rates have been  reported for children experiencing lead en-
 cephalopathy since  the inception  of chelation therapy as the standard  treatment approach:  39
 percent  (Ennis and Harrison,  1950);  20-30 percent  (Agerty,  1952); 24  percent  (Mellins  and
 Jenkins, 1955); 18 percent (Tanis,  1955); and  5 percent (Lewis et al.,  1955).   These data, and
 those  tabulated  more recently (National  Academy of  Sciences, 1972), indicate that once  lead
 poisoning has progressed  to  the  point of encephalopathy,  a life-threatening situation clearly
 exists and,  even with medical intervention, is apt  to result in  a fatal  outcome.   Historically
 there have  been  three  stages of chelation therapy.  Between  1946 and  1950,  dimercaprol  (BAL)
was used.   From 1950 to  1960,  calcium disodium ethylenediaminetetraacetate (CaNa2EDTA)  com-
pletely  replaced  BAL.   Beginning in 1960, combined  therapy with BAL and  CaNa2EDTA  (Chisolm
1968) resulted in a very  substantial reduction in mortality.
                                           12-68

-------
     Determining precise values for  lead exposures necessary to produce acute  symptoms,  such
as  lethargy,  vomiting,  irritability,  loss  of appetite,  dizziness, etc., or  later  neurotoxic
sequelae in humans  is  difficult in view of the  usual  sparsity of data on  environmental  lead
exposure levels, period(s)  of  exposure,  or body burdens of lead existing  prior to  manifesta-
tion  of  symptoms.   Nevertheless,  enough information is  available to permit  reasonable  esti-
mates  to  be made  regarding the range of  blood lead levels associated with  acute  encephalo-
pathic symptoms or death.   Available data indicate that lower blood lead levels  among children
than  among  adults  are  associated with acute encephalopathy symptoms.   The  most  extensive com-
pilation  of information on a pediatric  population  is a  summarization (National  Academy  of
Sciences, 1972)  of data from Chisolm (1962, 1965) and Chisolm and Harrison (1956).   This data
compilation relates occurrence  of  acute  encephalopathy and  death  in  children in Baltimore to
blood  lead  levels  determined  by  the  Baltimore City Health Department (using  the dithizone
method)  between 1930  and  1970.   Blood  lead  levels  formerly  regarded as  "asymptomatic"  and
other  signs of  acute  lead poisoning  were  also tabulated.  Increased  lead absorption  in the
absence of  detected symptoms was  observed  at  blood  lead  levels ranging from 60 to 300 M9/dl
(mean  = 105 ug/dl).  Acute lead poisoning  symptoms  other  than signs  of  encephalopathy were
observed  from  approximately  60 to  450 ug/dl  (mean = 178 ug/dl).   Signs of   encephalopathy
(hyperirritability,  ataxia, convulsions, stupor,  and coma) were  associated with  blood lead
levels of approximately 90 to  700 or  800 M9/dl (mean = 330 ug/dl). The distribution of blood
lead  levels associated with death (mean =  327 ug/dl) was  essentially  the  same as  for levels
yielding  encephalopathy.   These data suggest  that  blood lead levels capable of  producing death
in children are essentially identical to  those associated with acute  encephalopathy and that
such  effects are usually manifested  in children  starting at blood  lead  levels of approximately
100 ug/dl.   Certain other  evidence  from scattered medical  reports (Gant,  1938; Smith et al.,
1938; Bradley  et al.,  1956; Bradley  and  Baumgartner,  1958;  Cumings, 1959;  Rummo et  al., 1979),
however,  suggests  that acute encephalopathy  in the most  highly susceptible children may be
associated  with blood  lead levels  in the range  of 80-100 ug/dl.   These  latter  reports are
evaluated in detail in the 1977  EPA document Air Quality  Criteria for Lead  (U.S.  EPA, 1977).
      From the  preceding discussion,  it can  be seen that severity of symptoms  varies widely for
different  adults  or  children  at  increasing blood  lead  levels.  Some show irreversible CNS
damage or death at blood  lead levels  around  100 ug/dl, whereas others  may not  show any  of the
 usual clinical  signs of lead  intoxication  even at  blood  lead levels in the 100-200 ug/dl or
 higher range.   This diversity  of  response may  be  due  to  the following:   (1)  individual  bio-
 logical variation in  lead uptake  or susceptibility to lead effects;  (2) changes in blood lead
values from the time  of  initial  damaging  intoxication; (3) greater  tolerance  for  a gradually
 accumulating  lead  burden; (4) other  interacting or confounding  factors,  such as  nutritional

                                             12-69

-------
state or  inaccurate  determinations  of blood lead; or (5) lack of use of  blind  evaluation pro-
cedures on the part of the evaluators.  It should also be noted that a continuous  gradation of
frequency and severity  of  neurotoxic symptoms extends into the lower ranges  of lead  exposure.
     Morphologica-1  findings  vary  in  cases  of  fatal   lead  encephalopathy  among   children
(Blackman, 1937; Pentschew, 1965;  Popoff et al.,  1963).   Reported neuropathologic  findings are
essentially the same for adults and children.   On macroscopic examination the brains  are  often
edematous and  congested.   Microscopically, cerebral  edema,  altered  capillaries  (endothelial
hypertrophy  and hyperplasia),  and  peri vascular  glial   proliferation  often  occur.   Neuronal
damage is variable and  may be caused by anoxia.   However, in some cases  gross  and microscopic
changes are minimal (Pentschew, 1965).  Pentschew (1965)  described neuropathology  findings for
20 cases  of  acute  lead  encephalopathy in infants and young children.   The most common finding
was activation of intracerebral capillaries characterized by dilation of  the  capillaries,  with
swelling of  endothelial cells.  Diffuse astrocytic proliferation, an early  morphological  re-
sponse to  increased  permeability of  the  blood-brain barrier, was often  present.  Concurrent
with  such alterations,  especially  evident  in  the  cerebellum,  were  changes  that  Pentschew
(1965)  attributed  to  hemodynamic  disorders,  i.e., ischemic   changes  manifested   as   cell
necrosis, perineuronal  incrustations, and  loss of neurons, especially in  isocortex  and  basal
ganglia.
     Attempts have been  made to better understand brain changes associated with encephalopathy
by studying  animal models.   Studies of lead  intoxication in  the CNS of developing  rats  have
shown vasculopathic  changes  (Pentschew  and Garro, 1966), reduced cerebral cortical  thickness
and reduced number of synapses per neuron (Krigman et al., 1974a), and reduced  cerebral axonal
size  (Krigman  et al., 1974b).  Biochemical changes  in the CNS of lead-treated neonatal  rats
have also demonstrated reduced lipid brain content but no alterations of  neural  lipid composi-
tion  (Krigman  et al.,  1974a)  and a  reduced  cerebellar   DNA  content (Michaelson, 1973).   in
cases of lower level  lead  exposure,  subjectively  recognizable neuropathologic features may not
occur  (Krigman,  1978).    Instead  there  may  be  subtle  changes  at the  level  of  the  synapse
(Silbergeld  etal.,  1980a)  or dendritic  field, myelin-axon  relations,  and organization  of
synaptic  patterns  (Krigman,  1978).    Since  the nervous  system is a dynamic structure rather
than a static one,  it undergoes compensatory changes  (Norton and Culver,  1977),  maturation and
aging (Sotelo  and  Palay,  1971),  and  structural  changes  in response to  environmental  stimuli
(Coss and Glohus,  1978).   Thus, whereas massive structural damage  in  many cases  of  acute en-
cephalopathy would be expected to cause  lasting neurotoxic sequelae, some other  CNS  effects
due to severe early lead insult might be reversible or compensated for, depending  upon age and
duration of  toxic  exposure.   This raises  the question of whether effects of early overt lead
intoxication are reversible beyond the initial intoxication or continue to persist.

                                            12-70

-------
     In cases  of severe or  prolonged nonfatal  episodes  of lead encephalopathy, there  occur
neurological  sequelae qualitatively similar  to those often seen following traumatic or infec-
tious cerebral  injury,  with permanent sequelae  being  more common in children than  in adults
(Mel 1 ins and  Jenkins,  1955;  Chi solm,  1962,  1968).   The  most severe sequelae  in  children  are
cortical atrophy,  hydrocephalus,  convulsive  seizures,  and severe mental  retardation (Mellins
and  Jenkins,  1955;  Perl stein  and Attala, 1966;  Chi solm, 1968).   Children who  recover  from
acute lead encephalopathy  but  are re-exposed to lead  almost invariably show evidence of per-
manent central nervous system damage (Chisolm and Harrison, 1956).  Even if further  lead expo-
sure  is  minimized,  25-50  percent show  severe permanent sequelae,  such  as  seizure  disorders,
blindness, and hemiparesis (Chisolm and Barltrop, 1979).
     Lasting  neurotoxic sequelae  of  overt  lead  intoxication  in children  in the  absence  of
acute encephalopathy have also been  reported.   Byers  and Lord  (1943),  for example, reported
that 19 out  of 20 children with previous lead poisoning later made unsatisfactory progress in
school, presumably due to  sensorimotor  deficits,  short  attention span,  and behavioral  dis-
orders.  These  latter  types  of effects  have  since  been  confirmed in children with known high
exposures  to  lead,  but without a  history  of life-threatening  forms  of acute encephalopathy
(Chisolm  and  Harrison,  1956;   Cohen  and  Ahrens,  1959;  Kline,  1960).    Perlstein  and Attala
(1966)  also  reported neurological sequelae  in 140 of 386 children (37 percent) following lead
poisoning  without  encephalopathy.   Such  sequelae included mental retardation, seizures, cere-
bral palsy, optic  atrophy, and visual-perceptual problems  in some children with minimal intel-
lectual  impairment.   The  severity of sequelae  was related  to severity of  earlier observed
symptoms.  For 9 percent  of those  children  who  appeared to be without  severe symptoms at the
time  of diagnosis of overt  lead  poisoning,  mental  retardation was  observed upon  later follow-
up.   Since no control  group was  included  in their study, one may  question whether  the neuro-
logical  effects observed  by Perlstein  and  Attala (1966) were  persisting effects  of earlier
overt  lead intoxication without encephalopathy;  however,  it  is extremely unlikely that 37 per-
cent  of any  randomly selected  control group from the  general pediatric  population would exhi-
bit the types  of neurological problems observed  by  Perlstein and  Attala  (1966).
      Numerous  studies  (Cohen et al.,  1976; Fejerman et al.,  1973;  Pueschel  et al.,  1972; Sachs
et al., 1978,  1979, 1982) suggest that, in  the absence of encephalopathy,  chelation therapy
may ameliorate the  persistence of  neurotoxic effects  of  overt  lead poisoning (especially cog-
nitive,  perceptual,  and  behavioral deficits).   On the  other  hand,  one recent  study found a
residual  effect on  fine motor  performance even  after  chelation  (Kirkconnell  and Hicks,  1980).
      In  summary,  pertinent  literature  definitively  demonstrates  that lead poisoning with
encephalopathy results in a greatly  increased incidence of permanent  neurological  and  cogni-
tive impairments.    Also,   several  studies  further indicate that children with symptomatic  lead

                                             12-71

-------
poisoning in the absence of encephalopathy also show a later increased incidence  of  neurologi-
cal and behavioral impairments.
12.4.2.2.2  Non-overt lead intoxication in children.  In  addition  to  neurotoxic  effects  asso-
ciated with overt  lead  intoxication in children, substantial  evidence indicates  that  lead ex-
posures  not  leading to overt  lead  intoxication in children can induce neurological  dysfunc-
tions.  This  issue  has  attracted much attention and generated considerable  controversy during
the  past  10-15 years.  However,  the evidence  for and against the occurrence of significant
neurotoxic deficits at relatively low levels of lead exposure  has  been quite mixed and largely
interpretable  only  after  a  thorough critical  evaluation  of  methods employed in the various
important  studies  on  the  subject.   Based on  five  of the criteria listed earlier (i.e.,  ade-
quate markers  of  exposure  to lead,  sensitive measures,  appropriate subject  selection, control
of confounding  covariates,  and appropriate  statistical  analysis),  the population studies sum-
marized in Table  12-2  were conducted rigorously enough to warrant  at  least  some  consideration
here.  Even so, no epidemiologies! study is  completely flawless and,  therefore, overall inter-
pretation  of  such findings  must  be based  on evaluation of the following:    (1) the  internal
consistency and quality of  each  study;  (2)  the consistency of results obtained across  inde-
pendently  conducted  studies; and (3) the plausibility  of results  in view of other available
information.
     Rutter (1980) has  classified studies evaluating neurobehavioral  effects  of  lead  exposure
in non-overtly  lead intoxicated children according  to several  types,  including four categories
reviewed below:   (1)  clinic-type studies of children thought  to  be  at risk because of  high
lead  levels;  (2)  other studies of  children  drawn  from  general (typically urban or suburban)
pediatric populations;  (3)  samples  of  children living more specifically in  close proximity to
lead emitting smelters;  and (4) studies  of mentally retarded or behaviorally deviant children
Major attention is  accorded here to studies  falling under the first  three categories.    A
final section  discusses some  initial results beginning to emerge from long-term prospective
studies, which  attempt  to  relate effects on  early neuropsychological  development and  later
neuropsychologic functioning to lead exposure histories  for children  documented  back  to  birth
or even prenatally.
     12.4.2.2.2.1   Clinic-type studies of children with high  lead levels.     The  clinic-type
studies are generally typified  by evaluation of children with  relatively high lead body bur-
dens as identified through  lead screening programs or other large-scale programs focusing on
mother-infant  health  relationships and early  childhood development.
     De la Burde and  Choate (1972) observed  neurological  dysfunctions, fine  motor dysfunction
impaired concept formation,  and altered  behavioral  profiles in 70  preschool children  exhibit-
ing pica and  elevated  blood lead levels  (in  all  cases  above 30  ug/dl;  mean = 59 ug/dl) in  com-
parison with  matched  control  subjects  not  engaging  in  pica.   Subjects were drawn  from  the
                                          12-72

-------
                                       TABLE 12-2.   SUMMARY OF  STUDIES  ON NEUROBEHAVIORAL FUNCTIONS OF LEAD-EXPOSED CHILDREN9
tvj
 I
Population
Reference studied N/group
Age at Blood lead,
testing, yr ug/dl
(range) (range or tS.D.)
Psychometri c
tests employed
Summa
ry of results
Levels of .
significance
Clinic-type studies of children with high lead levels

de la Burde and Inner city C = 72
Choate (1972) (Richmond, VA) Pb = 70




de la Burde and Follow-up C = 67
Choate (1975) same subjects Pb = 70







4.0 ?C d
4.0 58 (30-100)°




7-8 PbT: 112 ug/g
7-8 202 M9/a







IQ (Stanford-
Binet) %
Fine motor
Gross Motor
Concept formation
Behavior profile
WISC Full Scale
IQ %
Verbal IQ
Performance IQ
Bender-Gestalt
Reading
Spelling
Arithmetic

Score:
subnormal




Score:
subnormal






Goodenough-Harris draw test



Rummo (1974); Inner city C = 45
RUMO et al. (Providence, RI) Pbj = 15
(1979) Pb2 = 20
Pbs = 10





Kotok (1972) Inner city C = 25
(New Haven, CT) Pb = 24



Kotok et al. Inner city C = 36
(1977) (Rochester, NY) Pb = 31








5.8 23 (±8)
5.6 ,, flx 61 (±7)
5.6 *•* *; 68 (±13)
5.3 88 (±41)





2.7 (1.1-5.5) 38 (20-55)
2.8 (1.0-5.8) 81 (58-137)



3.6 (1.9-5.6) 28 (11-40)
3.6 (1.7-5.4) 80 (61-200)





Auditory vocal assoc
Tactile recognition
Behavior profile
McCarthy Scales:
Gen. cognitive
Verbal
Perceptual
Quantitative
Memory
Motor
Parent ratings
Neurologic exam
Denver Develop-
mental :
Gross Motor
Fine motor
Language
IQ Equivalent:
Social
Spatial
Spoken vocal.
Info-conprehersion
Visual attention
Auditory memory
.


C
93
46
48
45
47
52
8
7/12 i

Norm
1.00-
i.oo!
1.00







C

:e 10
26
7
10
10
e 90
:e 6
9
13
27
7
11
7
1
13
3
3
Pbj
94
46
49
44
46
52
10
teasures

C
1.02
0.82
0.82
C
126
101
93
96
93
100
Pb
89
25
45
16
15
30
87
24
18
24
49
12
16
12
13
31
15
25
Pb2
88
44
46
41
43
50
10
sig.

Pb
1.06
0.81
0.73
Pb
124
92
92
94
90
93



















Pb3
77
37
38
35
36
40
18


<0.05
<0.05
N.S.
N.S.
<0.01

0.01
N.S.
N.S.
0.01
N.S.
N.S.
N.S.
0.02
0.01
0.05
0.001

<0.01
<0.05
<0.05
<0.01
<0.01
<0.01
<0.01
different



T
f









N.S.f
0.10
<0.10
>0.10
>0.10
>0.10
>0.10

-------
TABLE 12-2.  (continued)
Age at
Population testing, yr
Reference studied N/group (range)
Perino and f Inner city Low Pb = 50 3-6
Ernhart (1974)r (New York, NY) Hod. Pb = 30 3-6





Ernhart at al. Follow-up same Low Pb = 31 8-13
(1981V subjects Nod. Pb = 32




1— »
r\3
i
•-j
.pi
General Population Studies
Needlewan et al. Urban C = 100 7
(1979)" (Boston, MA) Pb = 58 7






NcBride et al. Urban/suburban Low Pb = MOO 4/5
(1982) (Sydney, Australia) Hod. Pb = >100 4/5







Blood lead,
ug/dl Psychometric Levels of .
(range or ±S.O.) tests enployed Sunwary of results significance
10-30 McCarthy Scales:
40-70 Gen. cognitive
Verbal
Perceptual
Quantitative
Memory
Motor
21 (±4)9 McCarthy Scales:
32 (±5) Gen. cognitive
Verbal
Perceptual
Quantitative
Memory
Motor
Reading tests
Conners teacher ratings
Various experimental tests
£
PbT: <10 pp» W1SC Full Scale IQ
>20 pp* Verbal IQ
Performance IQ
Seashore Rhythm Test
Token Test
Sentence Repetition Test
Delayed Reaction Time C
Teacher Ratings
2-9 ug/dl Peabody Picture
19-29 g/dl Vocab. Test
Fine Motor Tracking C >
Pegboard
Tapping Test
Bean Walk
Standing Balance C >
Rutter Activity
Scale
Low Mod.
90 80
44 39
44 37
48 44
45 42
46 42
Low Hod.
94 82
48 41
43 40
43 38
44 39
49 46
Mot Reported
Not Reported
Not Reported
C Pb
106. 6 102. 1
103.9 99.3
108.7 104.9
21.6 19.4
24.8 23.6
12.6 11.3
> Pb on 3/4 blocks
9.5 8.2
Low Mod.
-105 -104
Pb 1/4 comparisons
-20 -20
-30 -31
-5 -4
Pb 1/4 comparisons
-1.9 -2.1


<0.01
<0.05
<0.05
N.S.
N.S.
N.S.

<0.05
<0.05
N.S.
N.S.
N.S.
<0.05
N.S.
N.S.
N.S.

0.03
0.06
0.12
0.002
0.09
0.04
<0.01
0.02

N.S.
<0.05
N.S.
N.S.
N.S.
<0.05
N.S.


-------
                                                              TABLE 12-2.  (continued)
Reference

Yule et al.
(1981)





Yule et al.
(1984)

Population
studied

Urban
(London, England)





Same subjects
in Yule et al.
(1981)
Age at
testing, yr
N/group (range)

Group
Group
Group
Group




1 = 34 9
2 — 4o 9 /c-.i9\
3 = 49 8 l6 U)
4 = 35 8



Same Same




Blood lead,
tig/dl
(range or ±S.O.)


8.8J (7-10)
11.6
14.5
19.6



(11-12)
(13-16)
(17-32)



Same




Psychometric
tests employed
Summary
Group: 1
WISC-R Full Scale IQ
Verbal IQ
Performance IQ
Vernon Spelling Test
Vernon Hath Test
Neale Reading Accuracy
Neale Reading Compre.
Needleman Teacher
Ratings
Conners Teacher
t*_i. • 	 f
103
101
106
104
t 97
* 121
117
1.53
(4/11
0.
^ tm .*_ _
2
103
101
103
98
97
110
110
1.54
items
26
Levels of b
of results significance
3
96
95
98
92
95
96
95
2.45
4
96
94
99
89
95
89
88
2.63

0.027
0.043
0.102
0.001
N.S.
0.001
0.001
0.096
sig. different)
0.
37
jf\ /It \
0.04
ro
i
Lansdown et al.      Urban
  (1986)        (London,  England)
Low = 80
High = 82
    7-12
    13-24
Smith et al.         Urban          High =  155
  (1983)        (London,  England)    Med = 103
                                    Low = 145
                  6,7
                  6,7
                  6,7
PbT £ 8.0
PbT = 5-5.5
PbT < 2.5
£A11 in M9/8)
X PbB = 13.1
                                                    Ratings            (3/4 factors sig. at p <0.05)
                                                  Rutter Teacher       (2/26 items sig. at p SO.05)
                                                    Ratings, including (5/26 items differ at 0.05
-------
                                                                    TABLE 12-2.   (continued)
l\3
 I


CTi
Reference
Harvey et al.
Age at Blood lead,
Population testing, yr ug/dl
studied N/group (range) (range or ±S.D. )
Urban 189 2.5 15.5 (6-30)
(1983, 1984) (Birmingham, England)









Silva et al. (1986b)












Schroeder et al.
(1985)





Schroeder and
Hawk (1986)



Smelter Area Studies
Landrigan et al.
(1975)












Urban 579 11 11.1 (4-50)
(Dunedin, New Zealand)











Rural/urban 104 <2.5 or >2.5 6-59
(Wake County, (0.8-6.5)
North Carolina)


Follow-up same 50 6-12 S30
subjects
Rural /urban 75 2 21 (6-47)
(Lenoir and
Hanover Counties,
North Carolina


Smelter area C = 78 9.3 ,, ft,, „, <40
(El Paso, TX) Pb=46 8.3 lJ'e "•*' 40-68



Psychometric
tests employed
British Ability Scales
Naming
Recall
Comprehension
Recognition
IQ
Stanford-Binet Items
Shapes
Blocks
Beads
Playroom Activity
WISC-R Full Scale IQ
Performance IQ
Verbal
Rutter Behavior Rating
Parent
Teacher
Inattention Rating
Parent
Teacher
Hyperactivity Rating
Parent
Teacher
Burt Reading Test
Levels of t
S unwary of results significance
Regression F Ratio
<1
1.26
<1
<1
<1

<1
2.34
2.46
?
r = -0.06
= -0.03
= -0.05
R2 Incrs. by Pb
D~ZI 1.38
0.10 1.23

0.24 0.26
0.25 1.51

0.12 1.01
0.12 0.82
0.43 0.28

N.S.
N.S.
N.S.
N.S.
N.S.

N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.

0.003
0.008

N.S.
0.001

0.015
0.028
N.S.
Bayley HOI or Stanford- Regression analysis
Binet



Stanf ord-Bi net

Stanford-Binet





WISC Full Scale IQ"
WPPSI Full Scale IQ
WISC + WPPSI Combined
WISC + WPPSI Subscales

Neurologic testing
of sources for IQ
effect:
Lead: F = 7.689
SES: F = 20.159
Lead: F <1

Regression analysis of
IQ against:
Current PbB: F = 12.31
Max. Pb6: F = 10.55
Mean PbB: F = 10.08
C Pb
93 89
91 86
93 88
C > Pb on 13/14 scales
7/14 scales sig. different
C > Pb on 7/8 tests
1/8 tests sig. different


<0.01
<0.001
N.S.



<0. 0008
<0.0018
<0.002

N.S.
N.S.
N.S.

<0.05
<0.01

-------
TABLE 12-2.   (continued)
Age at
Population testing, yr
Reference studied N/group (range)
McNeil and Ptasnik Smelter area C = 37 9 ,, a ,„.,
(1975) (El Paso, TX) Pb = 101 9 1I-S'-U}J










Ratcliffe (1977) Smelter area Mod. Pb =23 4.7 (4.1-5.6)
(Manchester, Hi Pb = 24 4.8 (4.2-5.4)
England)




Winneke et al. Smelter area C = 26 8
(1982a) (Duisburg, FRG) Pb = 26 8




Winneke et al. Smelter area 89 9.4
(1983) (Stolburg, FRG)






Blood lead,
ug/dl Psychometric Levels of b
(range or iS.D. ) tests employed Summary of results significance
29 (14-39) McCarthy General
58 (40-93) Cognitive
WISC-WAIS Full Scale
IQ
Oseretsky Motor Level
California Person-
ality C >
Frostig Perceptual
Quotient
Finger-Thumb
Apposition

28 (18-35) Griffiths Mental Dev.
44 (36-64) Frostig Visual
Perception
Pegboard Test
Dominant hand
Nondominant hand
L
PbT = 2.4 ppm German WISC Full Scale
PbT =9.2 ppm Verbal IQ
No PbB Performance IQ
Bender Gestalt Test
Standard Neurological Tests
Conners Teacher Ratings
C Pb
82 81

89 87
101 97

Pb, 6/10 items

100 103

27 29
Mod. High
108 102

14.3 11.8

17.5 17.3
19.5 19.8
C Pb
122 117
130 124
130 123
17.2 19.6
2.7 7.2
? ?
N.S.

N.S.
N.S.

<0.05

N.S.

N.S.

N.S.

N.S.

N.S.
N.S.

N.S.
N.S.
N.S.
<0.05
N.S.
N.S.
PbT: 6.16 ppmh German WISC % Variance Due to PbT
PbB: 14.3 M9/dl Full Scale IQ
Verbal IQ
Performance IQ
Bender Gestalt Test
Standard Neurological Tests
Conners Teacher Ratings
Wiener Reaction Performance
-0.0
-0.5
+0.6
+2.1
+1.2
0.4-1.3
+2.0
N.S.
N.S.
N.S.
<0.05
N.S.
N.S.
N.S.

-------
TABLE 12-2. (continued)


Reference
Winneke et al.
(1984)









Age at Blood lead,
Population testing, yr M9/dl Psychometric
studied N/group (range) (range or ±S.D. ) tests employed


Summary of results

Levels of b
significance
Smelter area 122 6.5 8.2(4.4-22.8) German WISC % Variance Due to Pb
,(Nordenham, FRG) Short form
Verbal IQ
Performance
Bender Gestalt Test
Signalled Reaction Time
Short
Long
Wiener Reaction Tine
Easy
Difficult
-0.3
+0.3
-2.4
+0.5

+0.1
-0.2

+4.3
+11.0
N.S.
N.S.
N.S.
N.S.

N.S.
N.S.

<0.05
<0.01
  Abbreviations:  C = control  subjects; Pb =  lead-exposed subjects; MDI = mental development index; N.S. = nonsignificant (p >0.05); PbT = tooth lead;
,_. WISC = Wechsler Intelligence Scale  for Children; WPPSI = Wechsler Preschool and Primary Scale of Intelligence; RT = Reaction Time.
 i  Significance levels are those found after partial ing out confounding covariates.
oocUrinary coproporphyrin levels were  not elevated.
   Some with positive radiologic findings, suggesting earlier exposure in excess of 40-60 ug/dl.
  ePercent of each group scoring "borderline,"  "suspect," "defective," or "abnormal."
   Reanalysis of data by Ernhart correcting for methodological problems in earlier published analyses described here mainly did not substantiate significant
   differences between control  and  Pb-exposed  children indicated in last two  columns to the right (see chapter text).
  9Dentine levels not reported  for  statistical  reasons.
   Reanalyses of Needleman data correcting for  methodological problems in earlier published analyses confirmed significant differences between study groups
   indicated in last two righthand  columns for  WISC IQ test results (see chapter text).
  ^Hain measure was dentine  lead (PbT).
  •*Blood  lead levels taken 9-12 months prior to testing; none above 33 ug/dl.
  TJata not corrected for age.
   This F ratio is result of testing the difference in sums of squares for two regression equations (one including and one excluding blood lead level as an
   independent variable) against the residual nean square of the equation including blood lead.
  TJsed for children over 5  years of age.
  "Used for children under 5 years  of  age.

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Collaborative Study of Cerebral  Palsy,  Mental  Retardation, and Other  Neurologic  Disorders of
Infancy and  Childhood (Broman et al.,  1975),  which was conducted in  Richmond, Virginia,  and
had a  total  population  of 3400 mothers.  All  mothers  in this group were  followed throughout
pregnancy and all children were postnatally  evaluated by regular pediatric neurologic examina-
tions,  psychological testing, and medical interviews.  All  children subject to prenatal,  peri-
natal,  and early  postnatal  insults  were excluded from  the  study,  and all had to  have  normal
neurologic examinations and  Bayley  tests at eight to nine months of age.   These  are important
points which add  value  to the study.   It is  unfortunate that blood lead  data were not regu-
larly  obtained;  however,  at  the time of the study in the late 1960s, 10-20 ml of venous blood
was required  for a  blood lead determination  and  such  samples usually had to be  obtained by
either jugular or femoral  puncture.   The other control  features (housing location and repeated
urinary coproporphyrin tests) would be considered the state of the art for such a study at the
time that it was carried out.
     In  a follow-up  study  on the  same children (at  7-8 years old), de  la  Burde and Choate
(1975) reported  continuing  CMS impairment in  the  lead-exposed group as assessed by a variety
of  psychological  and neurological  tests.    In  addition,  seven  times  as many  lead-exposed
children were repeating grades in school or being referred to  the  school psychologist, despite
many of  their  blood lead levels  having  by  then  dropped significantly from the initial study.
In  general,  the  de  la Burde  and Choate (1972,  1975)  studies  appear to be methodologically
sound, having  many  features that strengthen the case for the  validity of their findings.  For
example,  there were  appreciable  numbers of children (67  lead-exposed and 70 controls) whose
blood  lead  values were obtained  in  preschool  years and who were  old  enough  (7  years) during
the follow-up  study to cooperate adequately for  reliable psychological  testing.   The psycho-
metric tests  employed were well  standardized  and acceptable as sensitive  indicators of neuro-
behavioral  dysfunction,  and the testing was carried out  in a  blind  fashion (i.e., without the
evaluators  knowing  which  were  control or lead-exposed subjects).
     The  de la Burde and Choate  (1972, 1975) studies  might  be criticized on several points,
but none  provide  sufficient  grounds  for rejecting their results.   One  difficulty is  that blood
lead  values were  not determined for control  subjects in the initial  study; but the lack of
history  of pica  for paint  and  plaster, as well  as tooth  lead  analyses  done  later for the
follow-up study, render  it  improbable  that appreciable numbers  of lead-exposed subjects might
have  been wrongly  assigned to the  control  group.   Subjects  in the control  group did have  a
history  of  pica,  but not  for paint.   Also,  results  indicating  no measurable coproporphyrins in
the urine of control  subjects  at  the time of  initial testing  further confirm  proper assignment
of  those children to the nonexposed control group.  A  second  point of criticism  is the  use of
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multiple chi-square statistical analyses,  but  the fact that the  control  subjects  did  signifi-
cantly  better  on  virtually every  measure makes it  unlikely that all  of the observed  effects
were due  to chance alone.  One last  problem concerns  ambiguities in subject selection which
complicate  interpretation  of  the   results  obtained.   Because the lead-exposed group  included
children with blood lead levels of 40-100 ug/dl,  or of  at least 30 ug/dl  with "positive radio-
graphic findings  of lead  lines  in the  long bones, metallic deposits  in the intestines,  or
both," observed deficits  might  be attributed to blood  lead  levels  as  low  as 30 ug/dl.  Other
evidence (Betts et al., 1973), however,  suggests  that such a simple  interpretation is  probably
not accurate.  That is,  the Betts et al.  (1973)  study indicates that  lead lines are  usually
seen only  if blood levels  exceed 60 ug/dl  for most  children  at some time during exposure
although some  (about 25  percent)  may show lead lines at blood lead  levels  of 40-60 ug/dl.   in
view of this,  the  de  la Burde and Choate  results  can  probably be most  reasonably interpreted
as showing  persisting  neurobehavioral deficits at blood lead levels of  40-60 ug/dl or higher.
     In another clinic-type child study,  Rummo (1974)  and  Rummo  et al.  (1979) found  signifi-
cant neurobehavioral deficits (hyperactivity,  lower  scores on   McCarthy  scales  of cognitive
function,  etc.) among  Providence,  Rhode  Island,  inner-city children who  had previously exper-
ienced high levels of  lead exposure that had produced acute lead  encephalopathy.   Mean maximum
blood  lead  levels  recorded for those children at  the  time of  encephalopathy were  88  ±  40
ug/dl.   However, children with  moderate  blood  lead elevation but not manifesting symptoms  of
encephalopathy were not  significantly different  (at p <0.05) from controls on any measure  of
cognitive functioning,  psychomotor performance, or  hyperactivity.   Still,  when the data  from
the  Rummo   et  al.  (1979) study for  performance on  the McCarthy General  Cognitive  Index  or
several McCarthy Subscales  are  compared  (see Table 12-2),  the scores for  long-term moderate-
exposure  subjects  consistently fall  below  those for  control  subjects and  lie  between the
latter  and  the encephalopathy group  scores.  Thus, it appears  that long-term moderate  lead
exposure,  in  fact, likely  exerted  dose-related  neurobehavioral   effects.   The  overall dose-
response  trend might  have been  shown   to   be  statistically significant  if  other  types  of
analyses were used, if  larger samples were assessed,  or if control subjects were restricted  to
blood lead values below 10 ug/dl.   However,  control  for confounding  variables in the different
exposure groups would  also have to be considered.   Note that (1)  the maximum blood lead levels
for the short-term  and long-term  exposure subjects  were all greater than 40 ug/dl  (means  =  61
± 7 and 68 ± 13 (jg/dl,  respectively),  whereas control  subjects all had blood lead  levels below
40 ug/dl (mean =  23 ±  8 ug/dl), and  (2)  the control  and lead-exposed subjects were inner-city
children well  matched  for  socioeconomic  background,  parental  education levels,   incidence  of
pica, and other pertinent factors, but parental IQ was  not ascertained and  controlled  for  as a
potentially confounding variable.

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     A  somewhat  similar pattern  of  results emerged  from a  study  by Kotok et al.  (1977)  in
which 36 Rochester, New York, control-group children with blood lead levels less than 40 ug/dl
were compared with 31 children having distinctly elevated blood lead levels (61-200 pg/dl) but
no  classical  lead intoxication  symptoms.   Both groups  were well matched  on  important back-
ground factors, notably including their propensity to exhibit pica.   Again, no clearly statis-
tically significant  differences  between the two groups were found on numerous tests of cogni-
tive and  sensory  functions.   However, mean scores of control-group children were consistently
higher  than  those of the lead-exposed  group for  all  six of the  ability  classes  listed, even
though  the control  group  included children that  had notably  elevated  blood  lead  values by
current medical  standards.   Kotok (1972) had reported earlier that developmental deficiencies
(using  the comparatively insensitive Denver Development Screening test) in a group of children
having  elevated  lead levels (58-137 ug/dl) were identical to those in a control group similar
in  age, sex, race, environment,  neonatal condition, and presence of pica, but whose blood lead
levels  were  lower (20-55 ug/dl).  Children in the lead-exposed group, however, had blood lead
levels  as  high as 137 ug/dl, whereas  some control children had blood lead  levels as high as 55
ug/dl.   Thus,  the  study essentially compared  two  groups with  different degrees of markedly
elevated  lead exposure  rather than  one  of lead-exposed  versus  nonexposed control children.
     Perino  and  Ernhart  (1974)  reported a  relationship  between neurobehavioral deficits and
blood  lead  levels  ranging  from  40  to 70  ug/dl  in a group of 80 inner-city preschool black
children,  based  on the  results  of  a cross-sectional  study including  children detected as
having  elevated  lead  levels via  the  New York  City lead screening  program.   One key  result
reported  was that the  high-lead  children  had McCarthy  Scale IQ  scores  markedly lower than
those of  the low-lead group  (mean IQ  =  80 versus  90,  respectively).   Also,  the  normal correla-
tion of 0.52 between parents'  intelligence  and  that  of their offspring was found  to be  reduced
to only 0.10 in  the lead-exposed group,  presumably  because  of the  influence of another factor
(lead)  that interfered with the normal intellectual  development of the  lead-exposed  children.
Another possible  explanation  for the  reported  results,  however, might be  differences  in the
educational  backgrounds of  parents of the control  subjects  when compared with  lead-exposed
subjects, because parental  education  level  was  found to  be significantly negatively related to
blood  lead  levels of the  children participating in the  Perino  and Ernhart (1974) study.  The
 importance  of  this  point  lies  in the fact that several other studies  (McCall  et  al.,  1972;
Elardo  et  al.,  1975;  Ivanans,  1975)  have  demonstrated  that higher parental  education levels
are associated with more  rapid  development and higher  intelligence  quotients  (IQs)  for their
children.
      Ernhart et al.  (1981)  were  able  to trace  and carry  out follow-up evaluations on 63 of the
80 preschool children  of the Perino  and Ernhart  (1974) study once they  reached school  age,
using  the McCarthy  IQ  scales, various  reading  achievement tests, the Bender-Gestalt test,  the
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Draw-A-Child test, and  the  Conners  Teacher's Questionnaire for hyperactivity.  The  children's
blood lead levels were reported to be significantly correlated with FEP  (r  =  0.51) and dentine
lead  levels  (r = 0.43),  but mean blood lead  levels  of  the moderately elevated group had  de-
creased after  five years.   When  control  variables  of  sex and parental IQ were extracted  by
multivariate  analyses,   the observed  differences  were  reported  to  be greatly  reduced  but
remained statistically significant for three of seven tests on the McCarthy scales in relation
to  concurrently  measured blood  lead  levels  but  not in  relation to the  earlier  blood  lead
levels or dentine  lead  levels  for the same  children.   This  led Ernhart et al. (1981)  to  re-
interpret their  1974  (Perino and Ernhart,  1974) IQ  results  (in which they had not  controlled
for parental education)  as either not likely being  due to lead or, if due to  lead, then  repre-
senting only minimal  effects on intelligence.
     The  Perino  and  Ernhart (1974)  and Ernhart et al.  (1981)  studies were  evaluated  by  an
expert committee  convened by EPA in March,  1983.   The committee reported (Expert Committee on
Pediatric Neurobehavioral  Evaluations, 1983) certain methodological  problems  associated with
the analyses published  by Perino and Ernhart (1974) and Ernhart et al.  (1981).  The committee
further recommended  that the Ernhart  data  set  be  reanalyzed to  deal with the methodological
problems.    Results of  reanalyses of  the  data have been submitted  by Ernhart  (1983,  1984-
Ernhart etal.,  1985).    Reanalysis  of relationships between preschool-age  children's  blood
lead  levels  and  concurrently  obtained McCarthy Scales  scores  (which included corrections  of
errors made  in the earlier, published  analyses for certain data calculations and  degrees  of
freedom used to determine statistical significance) revealed no statistically significant dif-
ferences (at p <0.05) due to lead; however,  lower  scores for the higher  lead  exposure group on
the General  Cognitive Index (GCI) did approach significance  at p <0.09.   Also, reanalysis of
relationships  between  preschool  lead levels  and  5-year  later school-age outcome variables
yielded no indication of persisting lead effects in terms of reading test results or scores on
the McCarthy GCI  or  most of the McCarthy Subscales (except for a p-value of  0.10 obtained  for
Verbal Index scores).   The  reanalysis  of  relationships between  school-age blood lead  levels
(newly corrected  for hematocrit  variation  effects)  and concurrent reading test and McCarthy
Scales  scores  only  found  significant  differences  attributable  to  lead  for lower McCarthy
Verbal Index scores  (p  <0.036  with a "deviant case" included in the analysis and p  <0.07 with
the case excluded).  Similar results were obtained  with  a different analysis  employing a "lead
construct index"  as  a measure  of lead exposure which combined preschool and school-age blood
lead  levels  and  free  erythrocyte  protoporphyrin   levels.   Based  on these  results, Ernhart
et al. (1985) concluded  that "the reanalyses provide no reasonable support for an interpreta-
tion of lead effects  in  these data."  However, she  also  noted that it is recognized  that there
was a certain level of unreliability in the  measures used and that the sample size limited  the

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power of the statistical  analyses.   Given such limitations and extensive attention accorded to
statistical control of potentially confounding variables in the reanalyses,  it is notable  that
an association  between lead  and  lower Verbal  Index  scores was nevertheless  observed  across
several of  the  analyses  (at  p values  ranging from <0.04  to 0.10)  and that an  association
between preschool  lead levels  and  General  Cognitive  Index scores  approached  significance at
p <0.09.   These  observations  (possibly  due  to chance  alone  from  among the  large  number of
statistical analyses  conducted) do  not provide much evidence  for  associations between neuro-
psychologic deficits  and  lead exposures at the levels  experienced  by children in the Ernhart
study population; conversely,  however, results of the  reanalyses do not allow for a definitive
conclusion of "no-effect," either (as noted by Ernhart, 1983).
     Other investigators  (Shapiro  and Marecek, 1984;  Marecek  et al.,  1983)  studied relation-
ships  between  lead exposures  and  psychometric testing outcomes among  black  children who had
been members of  the Philadelphia Collaborative Perinatal Project (CPP), which included mainly
families of  low  socioeconomic status.  From  among  a  large target  sample of eligible children
(those  young enough to have deciduous teeth and no past history of head trauma, mental retar-
dation, or lead poisoning) invited  to participate  in the  study (2,568 letters  of invitation
were mailed), 199  families enrolled their children.   Each child was scheduled for neuropsycho-
logic  testing immediately following the loss  of  a  tooth; primary  and/or circumpulpal dentine
lead  levels  from  shed deciduous  teeth  (mainly molars) were employed  to provide  an index of
lead exposure for  the  188 children (aged 10.6  to 14.7 yr; X = 11.8 yr) who underwent neuropsy-
chologic  testing.   Data  on  socioeconomic  status  and several other  potentially confounding
variables  were  obtained  from CPP records, and IQ  scores were obtained for  the parents  of a
subset  of  the children  studied.   Data  analyses  (hierarchical multiple regression analyses)
first  evaluated  relationships between dentine  lead exposure  indices  and test scores obtained
several years  earlier  (at  age 7 yr)  on the  Bender-Gestalt,  Wechsler Intelligence Scale for
Children  (WISC)  subtests,  and certain other  neuropsychologic  tests;  analyses were also per-
formed  using dentine lead data and  results from concurrently  administered psychometric tests.
For  the age-seven tests, significant  associations were  reported between dentine lead and per-
formance  IQ  scores, but  not  for  WISC verbal   IQ scores.   Similarly,  significant relationships
(at  p <0.05) were reported between  dentine lead values  and concurrently obtained  test  results
for  performance abilities  on the  Bender-Gestalt,  WISC, and  other tests but not  for verbal
abilities.   This study, while qualitatively  suggesting lead  may affect performance  abilities,
suffers from several  methodological  problems,  including inadequate control  for  sampling  bias,
retrospective estimation of age-seven  lead exposure  levels,  poor  control of  covarying social
factors, and inadequate  control  for parental  IQ influences  for all  children  studied.
      Odenbro et  al.  (1983)  studied  psychological  development  of children (aged 3-6 yr)  seen in
Chicago Department of Health  Clinics (August, 1976  -  February, 1977),  evaluating scores on the
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Denver Developmental  Screening test and  two subtests  of  the Wechsler Preschool and Primary
Scale of  Intelligence  (WPPSI)  in  relation to blood lead levels  obtained by repeated sampling
during the  three previous years.   A significant  correlation  (r = -0.435,  p <0.001) was  re-
ported between perceptual visual-motor  ability and mean  blood  lead levels.  Statistically sig-
nificant  (p <0.005)  deficits  in verbal  productivity  and perceptual  visual  motor performance
(measured by  the WPPSI) were  found for  groups  of children  with mean blood  lead  levels  of
30-40 |jg/dl  and  40-60 ug/dl  versus  control  children  with mean  blood  lead levels <25 ug/dl
using two-tailed  Student's  t-tests.  On  the other hand,  significant  associations  (p <0.05)
between blood  lead  levels and  developmental  retardations in language and fine-motor functions
were  found  only for  the 40-60 ug/dl group,  using the  Denver Development  Screening test  and
chi-square analyses.  These results  are  most clearly  suggestive of neuropsychologic deficits
being associated with blood lead  levels  of 40-60 ug/dl   in preschool children.  However, par-
ental IQs were  not  measured and questions can be raised regarding the  adequacy of the statis-
tical analyses  employed, especially in  regard to  lack of  use of multivariate analyses that
sufficiently control  for confounding covariates  such  as parental education and socioeconomic
status.
     In another  study (Molina  etal.,  1983), high-risk children  from families making lead-
glazed pottery  in a  Mexican village were evaluated for  lead-associated neuropsychologic defi-
cits, using  an appropriately   adapted  Spanish language  version  of the revised WISC (WISC-R)
test and  the  Bender-Gestalt test.   Test results  for 33 high-lead children  (X age:  10 yr, 7
mo ± 2 yr, 7 mo)  randomly  selected  from  64  school children  with blood  lead  levels above  4Q
ug/dl  (X:  63.4 ± 15.8 ug/dl)   were   compared  with  those for  30. lower  lead children  (X age:
10 yr, 2 mo ± 2 yr,  6 mo) with  blood lead levels below 40 ug/dl  (X: 26.3 ±8.0 ug/dl), using
the  two-tailed Student's t-test and the Mann-Whitney  U test.   The high-lead children were
found to  have significantly lower  WISC-R full-scale  IQ  (p <0.01),  verbal  IQ (p <0.01),  and
performance  IQ  (p <0.025) than did  the low-lead  control children,  who were  drawn from among
the  same  low  socioeconomic class  families as the  high-lead children.  A significant negative
linear correlation was  also observed for the same  categories  of test  scores  among  the high-
lead children,  but  not  for such  scores  among  the low-lead  children.   These results, highly
suggestive of  lead-related neuropsychologic  deficits  in children with  blood lead values over
40 ug/dl,  must be viewed with  caution  in light of  the  failure to include  parental  IQ levels
and  the lack  of  multivariate  statistical  analyses that  explicitly controlled for age, sex,  or
other confounding factors.
     In summary,  the  studies  reviewed  above generally  found  that  high-risk lead-exposure
groups did more poorly on IQ or other types  of psychometric tests than  referent control groups
with distinctly lower lead exposures.  It is  true that many of the studies did  not control  for
important confounding  variables  or, when  such were  taken  into account,  differences between
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lead-exposed and  control  subjects were  reduced  and,  at times, often no  longer  statistically
significant.  Still, the consistency  of  finding lower IQ values  and  other types of neuropsy-
chologic deficits among at-risk  higher lead exposure children across most of the studies  re-
viewed lends credence to cognitive deficits occurring in apparently asymptomatic  children with
markedly  elevated blood lead  levels   (i.e.,  starting  at 40-60 ug/dl and ranging  upwards  to
70-80 ug/dl and higher values).
     The magnitude  of lead's effects on  IQ  at the high  exposure levels  evaluated  in  these
studies is  difficult  to  estimate precisely due to variations in  measurement instruments  used,
variations  in the extent  to which various confounding factors were controlled for in the sta-
tistical analyses,  and  the  fact that  many  of  the  referent  control groups tended to have what
are  now recognized  to be  elevated  blood lead  levels  (i.e., averaging in the  20-40  ug/dl
range).   Focusing on estimates  of full-scale  IQ  deficits,  Rummo (1974;  Rummo  et al.,  1979)
observed a decrement of approximately  16 IQ points on the McCarthy GCI for postencephalopathic
children with blood lead values exceeding 80 M9/dl.  Asymptomatic children with long-term lead
exposures yielding  mean  blood lead values of 68 pg/dl  experienced an average 5-point IQ  (GCI)
decrement,  whereas  short-term lead-exposed  subjects  with blood  lead levels  around  60  |jg/dl
showed  no  decrement compared to controls.  The  de la Burde subjects, with  blood lead levels
averaging  58 ug/dl,  had a mean Stanford-Binet IQ decrement of 5 points upon first testing (de
la  Burde  and Choate,  1972) and  3 points  upon  follow-up  testing several years  later (de la
Burde  and  Choate, 1975).   Ernhart originally  reported  an  average 10 point IQ (GCI) decrement
for  children with blood lead values  in  the 40-70 pg/dl range upon first testing (Perino  and
Ernhart,  1974)  and  12 points upon follow-up  5 years later  (Ernhart  et  al.,  1981).  However,
these  reported  large  decrements  appear  to  be due  in part  to  confounding  by uncontrolled
covariates  in  the original  published  data calculations and, upon  reanalysis of the data (with
better  control  for  confounding  variables and with errors  corrected),  are apparently notably
reduced,  although  the  amount  of the reduction was not  clearly specified  in  the submitted
reanalyses.  While  it could be argued that the  Rummo and de la Burde decrements would also be
reduced  in size  if better control  for  confounding variables were employed, use of control
subjects  with  lower lead exposures (e.g.,  <10 |jg/dl)  could also  logically be expected to re-
sult in offsetting influences on  IQ.  Thus,  it seems warranted  to  conclude that the average
decrements  of  about  5  IQ  points  observed in  the de la Burde  and  Rummo studies represent a
reasonable  estimate  of  the  magnitude  of full-scale  IQ  decrements associated with notably
elevated  blood  lead levels  (X =  50-70 ug/dl)  in  asymptomatic children.
      12.4.2.2.2.2  General  population studies.   These studies  evaluated  samples  of  non-overtly
lead intoxicated children drawn  from  and thought to be  representative of  the  general  pediatric
population.  They generally aimed to  evaluate asymptomatic  children with lower  lead  body  bur-
dens than  those  of high-risk  children  evaluated in  most  of the above  clinic-type  studies.
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     A pioneering general  population  study was reported by Needleman  et  al.  (1979),  who used
shed deciduous teeth  to  index lead exposure.  Teeth were  donated  from 70 percent of a  total
population of  3329  first  and second grade  children  from  two towns near Boston.  Almost all
children who  donated teeth  (2146)  were rated by  their teachers on an 11-item  classroom be-
havior scale devised  by  the authors to assess attention disorders.   An apparent  dose-response
function was  reported for  ratings  on  the  behavior scale,  not taking  potentially  confounding
variables  into account.    After excluding  various  subjects   for control  reasons,  two  groups
(<10th  and >90th percentiles  of  non-circumpulpal  dentine  lead  levels)  were  provisionally
selected for  further in-depth  neuropsychologic  testing.   Later, some  provisionally  eligible
children were  also  excluded for various reasons, leaving  100 low-lead  (<10 ppm  dentine lead)
children  for   comparison  with  58  high-lead  (>20 ppm  dentine lead)  children in  statistical
analyses reported by Needleman et al.  (1979).  A  preliminary  analysis on 39  non-lead  variables
showed significant  differences  between  the low-  and high-lead groups for  age,  maternal  IQ and
education,  maternal  age at time of birth,  paternal  SES,  and paternal  education.   Some  of these
variables were entered as covariates into  an analysis  of covariance  along  with lead.   Signifi-
cant effects (p <0.05) were reported for full-scale WISC-R  IQ  scores,  WISC-R verbal  IQ scores,
for 9 of 11  classroom behavior scale items,  and  several  experimental  measures of  perceptual-
motor behavior.
     Additional papers published by Needleman and coworkers  have reported results  of  the same
or  further  analyses of  the data discussed  in the  initial paper by Needleman et  al.  (1979).
For example,  a paper by Needleman (1982)  provided a  summary overview of  findings  from the
Needleman et al.  (1979)  study and  findings reported by Burchfiel  et al.  (1980)  that  are dis-
cussed later in Section 12.4.2.2.2.7 concerning EEG patterns  for  a  subset  of children  included
in  the 1979  study.   Needleman (1982) summarized  results of an additional  analysis  of  the 1979
data set  reported   elsewhere  by Needleman  et al.  (1982).   More  specifically,  cumulative fre-
quency distributions  of  verbal  IQ  scores  for low-  and  Mgh-lead subjects from the 1979 study
were reported  by Needleman  et al.  (1982),  and  the key point made was  that the average  IQ
deficit of four  points  demonstrated by the  1979  study  did not just reflect children  with al-
ready low IQs  having their cognitive abilities further impaired.   Rather,  the entire  distribu-
tion of  IQ  scores across all  IQ levels was  reported  to be shifted  downward  in  the  high-lead
group, with  none of the  children in that group having verbal  IQs over 125.   Another  paper, by
Bellinger  and  Needleman  (1983), provided  still  further  follow-up  analyses of the  original
(Needleman et  al.,  1979) data  set, focusing mainly  on comparison of  the  low-  and  high-lead
children's observed versus  expected IQs based on their mother's IQ.   Bellinger  and  Needleman
reported that  regression analyses  showed  that IQs of children with elevated levels of dentine
lead (>20 ppm) fell below those expected based on  their mothers'  IQs  and  that  the  amount by

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which a child's IQ fell below the expected value increased with increasing dentine lead levels
in a  nonlinear  fashion.   Scatter plots of IQ residuals by dentine lead levels, as illustrated
and discussed  by Bellinger and  Needleman (1983),  indicated that regressions  for the  control
children with  dentine lead below  10  ppm and for high-lead children  with 20-29.9 ppm  dentine
lead  did not  reveal  significant associations between increasing lead levels in that range and
IQ residuals.   This  is in contrast to  statistically  significant (p <0.05) correlations found
between  IQ  residuals  and  dentine  lead for high-lead group children  with 30-39.9 ppm  dentine
lead  levels.
      The Needleman  et al.  (1979) study  and spin-off analyses published later by Needleman and
coworkers were critically evaluated  by the same Expert  Committee  on Neurobehavioral  Evalua-
tions  noted  above that was convened by  EPA in March, 1983, to evaluate the Peri no and Ernhart
(1974)  and  Ernhart  et al.  (1981)  studies.  The Committee's  report  (Expert Committee, 1983)
noted methodological  problems with certain of the the published analyses  and findings reported
by Needleman et al.  (1979) or in subsequent papers by Needleman and coworkers concerning addi-
tional  analyses  of the same data  set.   The Committee also recommended that the Needleman data
set be  reanalyzed.   Reanalyses carried  out in response to the  Committee's  recommendations have
been  reported by Needleman (1984),  Needleman  et al.  (1985),  and U.S.  EPA's Office of Policy
Analysis  (1984)  as   confirming  the  published  findings  on  significant  associations  between
elevated  dentine lead levels and  decrements in IQ, after  correcting errors in data calcula-
tions detected in earlier published  analyses  and  using alternative model  specifications that
incorporated better  control for  potentially  confounding factors.
      The  average magnitude of the  full-scale  IQ decrement attributable  to  lead  was estimated
in  the original published Needleman  analyses to be about 4 points  after  control  for confound-
ing  factors.   Based upon the  reanalyses submitted,  the  size of  the  full-scale lead effect
appears to remain  about the same (i.e., around 4  points) after controlling  for confounding
variables.   It is,  however, extremely  difficult to  define with  confidence  quantitative  dose-
response relationships based on the  Needleman  data,  beyond the  statement that average IQ de-
crements of about 4.0 points appear to be associated  with  lead exposure  levels experienced by
the  Needleman high-lead  group.  Among  that group,  statistically significant  (p  <0.05) IQ de-
crements appear  to  remain  (after controlling  for  confounding  variables)  for  children with
30-39.9 ppm dentine  lead  levels,  but not for children with 20-29.9  ppm  or lower dentine lead
 levels, as reported  by  Bellinger  and Needleman (1983).  Only  limited  data exist by which one
might  attempt  to estimate blood  lead  values  likely  associated with the  observed  IQ  effects;
 and the available information points broadly toward  an average blood lead concentration in the
 30-50 ug/dl range.   An  average  4-point full-scale  IQ decrement  associated  with average  blood
 lead  values  in  that range  would  be   consistent with  the mean 5-point  decrement  estimated
 earlier to occur at somewhat higher average blood lead levels  of 50-70 pg/dl.
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     Recently, Bellinger  et al.  (19845)  followed  up  on the academic performance of  a  subset
of the children  initially evaluated by Needleman  et  al.  (1979).   Of the 118 first  and  second
grade children who were  classified into low  (<10 ppm)  and  elevated (£20  ppm)  dentine  lead
groups by Needleman et  al.  (1979), 70 were  available for study 4 years  later.   In  addition,
71 children with  midrange tooth lead levels  (10.0-19.9 ppm) were included in the follow-up In-
vestigation.   Contemporary  blood lead  levels  could  not  be obtained.  Four types of outcome
measures were assessed:   (1)  standardized  IQ measures,  viz.,  the most  recently  available
scores  for  the  Otis-Lennon Mental  Ability Test,  as  routinely  administered  by the  school
system;   (2)  teacher ratings,  comprising a  24-item  pupil-rating  scale  and the  same 11-1tea
scale used  by Needleman  et al.  (1979);  (3) indices  of  school failure, i. e.,  remedial  In-
struction or  grade retention; and  (4)  direct  observation of classroom  behavior  patterns  re-
flecting inattention,  distractibility,  etc.  Various  statistical  analyses suggested  that  only
grade retention was clearly associated with  past  dentine lead levels; other outcomes  tended to
be in the predicted direction  of effect  but generally at p values between 0.05 and  0.15.   Of
some note is the fact that the teacher rating scale revealed no effect of lead, a finding  that
contrasts with  earlier  results  of Needleman  et  al.  (1979)   and  a more  recent replication
(albeit without control  for social  factors)  by  Yule et al. (1984).
     A study  of  urban  children in  Sydney, Australia  (McBride  et  al., 1982) involved 454  pre-
schoolers (aged  4-5 yr)  with blood lead  levels of 2-29 ug/dl.   Children born  at the Women's
Hospital in Sydney were recruited  via personal letter. No blood  lead measures were  available
on non-participants.  Blood levels  were evaluated at the time of  neurobehavioral  testing,  but
earlier exposure history was apparently not assessed.   Using a multiple statistical  comparison
procedure and Bonferroni correction to protect  against study-wise  error,  no statistically  sig-
nificant differences were found between two  groups with blood lead levels more than  one  stand-
ard  deviation above and  below the mean  (>19  ug/dl  versus  <9 ug/dl) on  the  Peabody Picture
Vocabulary IQ Test, on  a parent rating  scale  of  hyperactivity devised by Rutter, or on three
tests of motor ability  (pegboard,  standing balance, and finger tapping).   In one test of  fine
motor coordination (tracking), five-year old  boys in  the higher  lead  group  performed worse
than boys in the lower lead group.  In one test  of gross motor skill (walking balance), results
for  the  two age groups were conflicting.   This  study suffers  from  many  methodological weak-
nesses and cannot be regarded as providing evidence for or against an effect of low-level  lead
exposures  in  non-overtly  lead  intoxicated  children.  For example,  a  comparison of  socio-
economic status  (father's  occupation  and mother's education)  of the  study sample  with  the
general   population showed that  it  was higher   than  Bureau  of  Census  statistics  for  the
Australian work  force as  a whole.   Also, there was apparently some self-selection bias  due to
a high, proportion of professionals  living near  the hospital, and certain other important demo-
graphic variables,  such as mother's IQ, were not evaluated.
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     Another recent large-scale  study  (Smith et al., 1983) of  tooth  lead,  behavior,  intelli-
gence, and  a variety  of  other psychological  skills  was  carried out in a  general  population
sample of over  4000  children aged 6-7 years  in  three London boroughs.   Of  the  2663  children
who donated  shed  teeth for analysis, 403 children were  selected to form six groups,  one each
of  high  (8 ug/g  or  more), intermediate (5-5.5 ug/g), and  low (2.5 ug/g or  less)  tooth lead
levels for  two  socioeconomic groups (manual versus non-manual  workers).   Parents were inten-
sively  interviewed at  home regarding  parental  interest and  attitudes  toward  education  and
family characteristics  and relationships.   The early history of the child was then studied in
school using tests of intelligence (WISC-R), educational  attainment, attention, and other cog-
nitive tasks.   Teachers and  parents completed the Conners  behavior  questionnaires.   Results
showed that intelligence and other psychological measures were strongly related to social fac-
tors, especially  social  grouping.   Lead level was linked to a variety of factors in the home,
especially  the  level  of cleanliness and,  to a lesser extent,  maternal  smoking.   Before cor-
recting  for confounding factors,  there were significant associations between  lead and full-
scale IQ scores; however,  upon correcting for confounding factors, there were no statistically
significant  associations between lead  level and IQ or academic performance.  Also, when rated
by  teachers  (but  not by parents),  there were  small,  reasonably consistent (but not statisti-
cally  significant) tendencies for  high-lead children to show  more behavioral  problems after
the different social covariables were taken  into account statistically.
     The Smith  et al.  (1983) study  has much to recommend it:   (1) a well-drawn sample of ade-
quate  size; (2)  three tooth lead groupings based on well-defined classifications minimizing
overlaps of exposure  groupings based on whole tooth  lead values,  including quality-controlled
replicate  analyses for the  same tooth and duplicate analyses  across multiple teeth from the
same  child;  (3) blood lead  levels on a subset of 92  children which correlated reasonably well
with tooth  lead levels  (r  =  0.45);  (4) cross-stratified design  of  social groups;  (5) extensive
information  on  social  covariates and exposure sources; and (6)  statistical  control for  poten-
tially confounding covariates in the analyses of study results.   It should  also  be noted that
further  statistical  analyses of the Smith  data,  using tooth lead  as a  continuous variable or
finer-grain categorization  of  subjects  into eight tooth  lead exposure  groups, have  recently
been  reported  (Pocock  and Ashby, 1985) to confirm  no statistically significant associations
between  tooth lead and IQ  across  the entire spectrum  of  lead  exposure levels  present among the
study  population.   Interestingly, the average  full-scale  IQ values for the  medium- and high-
lead  groups in  the Smith  study  were 2 points below  the  average value  for the  control  group.
Also,  blood lead  values  for  subsets  of the children in the medium and high groups  averaged
12-15  ug/dl  (with all  but  one <30 ug/dl) upon  sampling within a few months  of neuropsychologic
testing  around  age six.   Somewhat  higher  blood lead values  may have been  obtained if sampled

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at  earlier  ages for  these  children (given  typical  peaking of blood leads seen  in  preschool
children), but likely would have still  fallen mainly in the 15-30 |jg/dl  range.
     Harvey  et  al.  (1983,  1984)  also recently  reported on  a  study involving 189  children,
average age  2.5  years and 15.5 ug/dl blood  lead,  from the inner city of Birmingham,  England.
The investigators utilized a wide range of psychometric tests, behavioral  measures of  activity
level, and psychomotor  performance.   They found that blood lead made no significant  contribu-
tion to IQ decrements after appropriate allowance had been made for social  factors,  although,
consistent with  findings from  the  Lansdown et  al.  (1986) study discussed below, a  stronger
correlation  between  IQ and  blood  lead  levels  was found  in  children of manual  workers  (r  =
-0.32) than  in  children of non-manual  workers  (r  =  +0.06).   Strengths  of this study are the
following:   (1)  a  well-drawn  sample;  (2)  extensive  evaluation  of  15 confounding  social
factors;  (3)  a  wide  range of abilities  evaluated; and (4) blind evaluations.   The finding of
no  significant  associations  between  lead and IQ decrements at the relatively  low  blood  levels
evaluated are consistent with the Smith study results discussed above for children in  the same
exposure range.
     Yule et al. (1981) carried out a pilot study on the effects of low-level  lead exposure on
85  percent of a population of  195 children  aged 6-12 years, whose  blood lead  concentrations
had been  determined  some nine months earlier as part of a European Economic Community survey.
The blood lead  concentrations  ranged  from 7 to  32  ug/dl, and the children were assigned to
four quartiles  encompassing  the following values:  7-10 ug/dl;  11-12 ug/dl;  13-16 ug/dl; and
17-32  ug/dl.   The tests  of achievement  and  intelligence were  similar to those  used  in the
Lansdown  et  al. (1974)  and Needleman et al.  (1979)  studies.   Significant associations were
reported  between  blood  lead  levels  and  decrements  in  IQ  (full-scale  IQ scores  averaged ~7
points  lower for the  highest lead group),  as  well  as  lower scores on  tests  of reading and
spelling, but not mathematics (Yule et al., 1981).  These differences in performance  (although
reduced in  magnitude)  largely  remained  statistically significant at p <0.05 after age,  sex,
and father's occupation were  taken  into account.  However,  other  important  potentially con-
founding  social  factors such as parental IQ were not controlled in this study,  and the  inves-
tigators  cautioned   against  interpretation  of  their  results  as  evidence  of  relationships
between lead and IQ  or functioning at  school  without  further  confirmatory  results  obtained
after better control  of social factors and other confounding variables.
     Lansdown et al.  (1986)  replicated their earlier pilot study (Yule  et al.,  1981)  with 194
children  (X  age  = 8.8 yr) living in a predominantly working area of London near  a busy road-
way.   In  this second,  better designed  study,  a lengthy structured  interview yielded data on
sources of  exposure, medical  history,  and many  potentially  confounding  variables,  including
parental  IQ  and  social  factors.   Analyses of covariance were used to evaluate  the effects of

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lead and  other factors  on  WISC-R verbal,  performance,  and full-scale IQ scores,  as  well  as
reading accuracy and  comprehension  scores,  for children with low (7-12 M9/dl) versus elevated
(13-24 ug/dl) blood lead  levels.   No significant effect of  lead was evident even before con-
sidering social class.   However,  there was some suggestion of a trend in effects on IQ in the
manual  working-class children when compared with non-manual working-class children.
     In another study,  Yule  and Lansdown (1983) evaluated  302  children (X age = 9 yr) living
in Leeds, England.   Tests and procedures similar to those employed in the previous two studies
were used  and, in  addition,  a reaction  time test  was  employed (Hunter  et  al.,  1985).   The
Leeds children were divided, for statistical analyses of the data, by (1) social class (manual
versus non-manual) and (2) blood lead level (low = 5-11 ug/dl; high = 12-26 M9/dl).   As in the
London  replication study,  no  statistically significant  relationships  for any  of the  IQ  or
reading performance scores  were found even before social class was controlled for in the sta-
tistical analyses.   The  high-lead  children averaged essentially identical  or  very slightly
better than  control  subjects  on several outcomes.   On the other hand, small  but statistically
significant  (p  <0.05)  changes   in reaction  time  (shorter for 3-sec  delays;  longer  for 12-sec
delays) were found and  appeared  to  parallel  a similar  pattern of  reaction  time  effects  of
larger  magnitude  reported by  Needleman et al.  (1979) for American  children  with higher lead
exposures.    Analyses  of covariance,  controlling for age, revealed that the reaction-time dif-
ferences between  low- and high-lead  children  in Leeds were only significant  for the younger
children (aged 6-10 yr) but not for the older children (aged 11-14 yr).
     Another paper  by Yule  et al. (1984) reported on the use of  three different teacher ques-
tionnaires (Needleman,  Rutter,  and  Conners) to assess attention  deficits  in the same children
evaluated  in their earlier  report (Yule  et al.,  1981).   While  there were few differences be-
tween  groups on the Rutter Scale, the  summed scores on the Needleman questionnaire across the
blood  lead groupings  approached  significance (p =  0.096).  Three  of the questionnaire items
showed  a  significant  dose-response  function ("Day  Dreamer,"   "Does  not Follow  Sequence  of
Direction,"  "Low  Overall  Functioning").   Nine of 11  items  were  highly   correlated  with
children's  IQ.   Therefore,  the  Needleman  questionnaire  may be  tapping  IQ-related attention
deficits as  opposed to measures of conduct  disorder  and socially  maladaptive behavior  (Yule et
al.,  1984).   The hyperactivity factors  on  the Conners and Rutter  scales  were reported to be
related  to blood  lead levels  (7-12 versus  13-32 (jg/dl), but the  authors noted that caution is
necessary  in  interpreting  their  findings  in view  of the  crude measures of social  factors
available  and the  differences between  countries  in diagnosing  attention deficit  disorders.
Moreover,  since the blood lead values  reported  were determined  only once (nine  months  before
psychological  testing),  earlier lead  exposure may not be fully  reflected  in the  reported blood
lead  levels.  However,  even  if  somewhat higher earlier,  it is  likely  that the  blood  leads
still  mainly fell  in  the  15-30 |jg/dl  range  for the higher  two quartile  groups.
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     Two recent reports by Schroeder and his colleagues (Schroeder et al., 1985;  Schroeder and
Hawk, 1986)  are  of particular importance to the  issue  of lead's effects on children's cogni-
tive functioning.  Although  these  studies dealt with children who had been identified through
lead-screening programs or who were potentially at risk for elevated lead exposure,  the actual
blood lead  levels  measured in these children were,  overall,  in line with or  not much higher
than the levels in the general population studies discussed above.
     Schroeder et  al.  (1985) evaluated 104 lower  SES  children, ages 10 months to  6.5 years.
Approximately half of the children (age <30 months) were tested on the Bayley Scales of Mental
Development; the remainder  of the  subjects (age >30 months) were tested on the Stanford-Binet
Intelligence  Scale.    Several  other  variables  were also assessed,  including  Caldwell  and
Bradley  (1979)  HOME  scores  and  parental  IQ,  SES,  education,  and employment.  Venous  blood
samples obtained on the day of testing were analyzed for lead concentrations and  ranged from 6
to 59 pg/dl  (X  = 30 ug/dl).  Statistical  analysis  of the data involved a form of  hierarchical
backward stepwise  regression.  Lead  was found to be a significant (p <0.01) source  of the ef-
fect on  IQ  scores  in these children after  controlling  for SES, HOME score, maternal  IQ,  and
other  social factors.   SES  was  the  only  other  variable  to reach  statistical  significance
(p <0.001);  other  variables apparently  failed  to reach  significance because  of  collinearity
with SES.  A corollary study of the same children by Milar et al.  (1981a) found no association
between lead exposure and hyperactivity.
     Fifty of the children were re-examined 5 years later, at which time all  blood lead levels
were 30  ug/dl or lower.   In addition to re-evaluating the children with the Stanford-Binet IQ
test, the  investigators  repeated SES  and maternal IQ (but not HOME) measurements.   Although
the 5-year  follow-up  IQ  scores were negatively correlated with both contemporary and initial
blood  lead  levels, the effect of  lead was  not significant after  covariates  (especially SES)
were included  in the regression model.   It  is  interesting to note  also  that  the correlation
between maternal and  child IQ was  only about 0.06 for children with initial  blood lead levels
of 31-56 ug/dl,  but  returned to a nearly normal  value  of 0.45 after 5  years,  when  blood lead
levels  had  dropped.   Similar  findings  have been  reported by  Perino  and Ernhart  (1974)  and
Bellinger  and  Needleman  (1983),  and  have  been  used  to argue  that an  environmental  factor
(i.e.,  lead) disrupts  the  normal  mother-child IQ  correlation  of  about  0.50.   Thus, Schroeder
et al.'s  (1985)  finding provides  further,  indirect  evidence of  lead's  disruptive  effect on
children's  cognitive  functioning at  blood  lead  levels  in the  range of  approximately  30-60
ug/di.
     Schroeder and Hawk  (1986)  replicated the above study with 75 Black children,  all of low
SES and  ranging  in age from 3 to 7  years.   Blood lead levels averaged  21 ug/dl  (range:   6-47
|jg/dl).   Backward  stepwise  multivariate regression analysis revealed a  highly significant re-
lationship between contemporary  blood  lead  level  and IQ (p <0.0008); the effect  was nearly as
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rtnhn, (p <0.002) whether

            „  c,osest.   SES was „„,  . s,.gnificant

                         anaiyses sh°"ed HOME
                            or mean blood ,ead va,ues    om



                                                                          «'. a


                   °"  IQ  wwrrt  to extend Hne.Hy across the entire range gf b]ooa

               In  fact, 78  percent  of  the subjects  had blood  ,ead ,.„„  be,ow 30
  tu
  00
  oco
  Otf)
               120



               110



               100



                90



                80



                70



                60



                50
                 I
 •


J	I
I
I   	I
                10     15    20    25     30     35    40



                             BLOOD LEAD LEVEL.
                                                                       46     50
           Figure 12-2. Regression of IQ scores against blood lead levels, with 95%

           confidence band. Double values indicated by triangle.


           Source:  Schroeder and Hawk (1986).
           investigation  that should be ^ed  here  has  been  reported by Silva et al

Thls preTiminary  study investigated cognitive development and behavior  problems in
                                 12-93

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579 11-year-old children  in  Dunedin,  New Zealand.   Higher SES groups were significantly over-
represented in  this  sample,  but the correlation between  blood levels and SES was  near zero.
The mean blood  lead  level  at age 11 was 11.1 ug/dl (SD = 4.91).   No significant  effects on IQ
were evident from an analysis of WISC-R scores.   Regression analyses and multiple correlations
were performed  on  scores  from a reading ability test, the Rutter parent and teacher question-
naires, and other  assessments  of children's inattention and hyperactivity derived from parent
and teacher reports.   The  contribution of blood lead levels to the explained variance for the
reading ability scores  was  nonsignificant.   However, five of the six remaining assessments of
children's behavior  showed  significant increases  in the amount of explained variance when the
blood  lead variable  was added.   Although blood lead accounted for only 0.8-1.2 percent of the
additional variance, the  results nonetheless indicate some association  between  lead exposure
and small  but  significant  adverse effects on behavior in older children, even after allowance
for certain  background factors  (e.g., maternal verbal  ability, maternal  depression,  a com-
posite  index  of social disadvantage).   A complementary report by  Silva  et  al.  (1986a) noted
that some  of the  children  in the  Dunedin pilot  study had had  significant  exposure  to lead
through paint-stripping activities in  the home.   Although  only two  subjects had  blood lead
levels above 30 pg/dl  at  the time of  testing,  this  backgorund information points up the need
for earlier and more precise characterization of  long-term  lead exposure for an accurate in-
terpretation of the Dunedin findings.
     None of the general population studies reviewed here individually provide definitive evi-
dence  for  or  against neuropsychologic deficits being associated with relatively  low body lead
burdens in non-overtly lead-intoxicated children representative  of general  pediatric popula-
tions.   The  recent report  by Schroeder and  Hawk (1986)  indicates a highly significant linear
relationship between a measure  of IQ  and  blood  lead levels over the  range  of 6 to 47 M9/dl.
This effect was almost equally as strong regardless of whether contemporary, past maximum, or
mean blood lead levels were used in the  analysis.   Because the subjects were all Black chil-
dren of uniformly  low  socioeconomic status, SES was not a significant covariate  in the analy-
sis.   On the other hand, this feature of the study limits the applicability of the findings to
the general  U.S.  population of children.   It is possible that SES and lead exposure interact
such that  IQ  is affected by blood  lead at lower SES levels but not at higher SES levels (cf.
Schroeder  et al.,  1985).   Findings  of stronger correlations between  IQ and blood lead levels
in  children  of manual  working  class  fathers  (Harvey etal., 1983,  1984;  Yule  and Lansdown,
1983;  Lansdown  et al., 1986) are  consistent with  this supposition  (cf.  Winneke and Kraemer,
1984).   If true,  this  interactive relationship would  suggest  that lower socioeconomic status
places  children at  greater  risk  to  the  deleterious effects of low-level  lead  exposure on
cognitive  ability.   However, as results  from  Schroeder et al.  (1985)  and  Schroeder and Hawk

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(1986)  indicate,  other variables  such  as HOME  scores  and maternal  IQ may covary  with  SES.
Other work  (e.g.,  Milar  et al., 1980; Dietrich  et  al.,  1985b) points to the home environment
as a  significant  predictor of lead exposure.   This  close relationship between SES, quality of
home environment,  and  lead exposure suggests that SES may  not be the sole  determiner  of in-
creased risk for cognitive impariment.  Further research is needed to disentangle the relative
contributions of these variables to the neurotoxic effects of lead.
     Of the  other studies reviewed here, the Needleman analyses may be interpreted as provid-
ing acceptable evidence for full-scale IQ deficits of about 4 points and other neurobehavioral
deficits being  associated with lead exposures of American  children resulting in dentine lead
values  that  exceed 20-30 ppm and  likely  average blood  lead values in the  30-50 ug/dl  range.
The report  of  recent analyses by Schroeder et al. (1985) supports this conclusion, even after
the major  influence of SES was allowed for in the analyses.  However, their findings indicate
that  the effect of blood  lead  on  IQ  could not  be detected five  years  after the original as-
sessment.  A follow-up by  Bellinger et al. (1984b) of the children studied by Needleman et al.
(1979)  suggests that  other  measures  of  classroom  performance may  show long-term effects of
early lead exposure more  effectively than  IQ measures (see also Silva et al., 1986b).  Shaheen
(1984)  has also questioned the  sensitivity of IQ scores and has suggested that the variability
in  outcomes of  studies  of lead's  effects on neuropsychological  functioning  in children may
originate  with differences  in the ages  at  which children are subjected  to toxic lead expo-
sures.
      For  the most part,  the  remaining  general  population  studies reviewed  in this section
report  a lack  (with a  few  exceptions)  of  statistically significant effects  on IQ or other
neuropsychologic  measures.  Most of the  remaining  studies  found  slightly lower  IQ  scores for
higher-lead  exposure groups than for  low-lead control groups before correcting for confounding
variables,  but the differences were  typically reduced  to 1-2 IQ points and were  non-signifi-
cant  (usually  even  at p <0.10) upon correction for  confounding  factors.   The  following con-
clusions  may  be  stated  about  these  latter  results:   (1) they are  suggestive  of  relatively
minimal (if any)  effects  of  lead on IQ in general populations, especially  in comparison to the
much  larger effects of  other factors (e.g.,  social variables), at  the  exposure levels evalu-
ated  in these  studies (blood lead values mainly in the  15-30 |jg/dl  range); and  (2) they are
not  incompatible with findings of significant lead effects on IQ  at  higher average  blood lead
levels  (£30 ug/dl).
      The few  exceptions  to  the general   pattern  noted  above  warrant comment here.   The  pilot
study  by  Yule et al.  (1981,  1984),  which  found  significant (6-7  point)  IQ  decrements  and
poorer  ratings on  several categories of classroom behavior,  has  certain  methodological  limi-
tations; specifically,  the  study provided  only relatively  crude control for socioeconomic
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factors  (as  noted by the authors) and  it failed to take parental IQ into account at all.   In
comparison  to  other studies,  the reported  IQ  decrements of about  6-7  points  are consistent
with neither (1) the maximum 1-2 point IQ differences seen in other general population studies
of  children  with  comparable lead exposures  (mainly  in  the 15-30 (jg/dl blood lead range),  nor
(2) the  results  of clinic  studies showing  4-5  point IQ decrements  at  distinctly higher lead
levels  (i.e.,  at  >30 ng/dl).    However,  the  findings  of altered  reaction time  patterns  by
Hunter  et al.  (1985), which parallel  those reported by Needleman at  higher exposure levels,
are somewhat more credible and appear to argue  for probable effects of  lead on  attention  or
vigilance  functions at  levels  extending below  30 pg/dl  and,  possibly,  down  to as  low  as
15-20 pg/dl.
     12.4.2.2.2.3  Smelter area studies.  The smelter studies evaluated children with elevated
lead  exposures  associated with  residence in cities or elsewhere in close  proximity  to lead-
emitting  smelters.   Most of the early studies,  conducted in the 1970s,  found  mixed results
even though  evaluating  children with blood  lead  levels  typically in excess of 30 ug/dl.  Be-
cause of methodological weaknesses, however, virtually all of the early studies must be viewed
as  inconclusive.
     For  example,  in  an early  study of this type Lansdown et al. (1974) reported a relation-
ship  between blood lead  level  in children  and the distance they lived from lead-processing
facilities,  but  no relationship  between  blood  lead level and  mental  functioning.   However,
only  a minority  of the  lead-exposed cohort had blood  lead  levels markedly differing from
control  subjects  with  elevated blood lead levels (<40 ug/dl).   Furthermore, this study failed
to adequately consider important confounding factors such as socioeconomic status.
     In another study, Landrigan et al. (1975) found that lead-exposed children living near an
El  Paso,  Texas,  smelter scored significantly lower  than  matched controls on measures of per-
formance  IQ  and  finger-wrist tapping.   The  control  children in  this study were,  however,  not
well matched by  age or sex to  the lead-exposed group, although the results remained statisti-
cally  significant after adjustments were made  for age differences.   In  contrast,  McNeil  and
Ptasnik  (1975) found  little evidence of  lead-associated decrements  in  cognitive  abilities  in
another  sample of children living near the  same  lead smelter  in El  Paso.  These children who
were generally comparable  medically  and psychologically to matched  controls living elsewhere
in  the  same city  except  for the direct  effects  of lead (blood  lead  level,  free erythrocyte
protoporphyrin levels,  and  X-ray findings).   An  extensive  critique  of  these  two  El  Paso
studies was  performed by another expert  committee (see Muir,  1975), which  concluded  that  no
reliable  conclusions could be  drawn from either  of the published studies  in view of various
methodological  and other problems affecting their conduct and statistical analyses.
     A later study  by  Ratcliffe (1977) of children  living near  a battery factory in Manches-
ter, England, found no significant associations between blood lead levels sampled at two years
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of age (28 ug/dl versus 44 ug/dl  in low- versus high-lead groups) and testing done at age five
on the Griffiths Mental  Development Scales, the Frostig  Developmental  Test  of Visual  Percep-
tion, a  pegboard test,  or a behavioral  questionnaire.   The differences  in  scores,  although
small, were  somewhat better for the  low-lead  exposure children than for  the  higher exposure
group.  The small  sample size (23 low-lead and 24 high-lead children),  inadequate control  for
parental   IQ,  and  the failure  to  repeat  blood lead  assays  at age  five  weaken  this  study.
Variations in blood  lead levels  occurring after age two among control children may have less-
ened exposure differences between the low- and high-lead groups, and larger sample sizes would
have better allowed for detection of any lead effects present.
     The more recent  smelter studies, described next, provide  assessments that generally ac-
cord somewhat greater attention to control for potentially confounding factors.  Also,  some of
the  studies assessed  larger samples of children, presumably allowing more accurate estimation
of any lead effects present.
     Two  studies by  Winneke and colleagues, the  first a pilot  study (Winneke et al.,  1982a)
and  the  second  an extended  study  (Winneke  et  al., 1983), employed  tooth  lead analyses anal-
ogous to  some  of the studies already discussed above.  In the pilot study, incisor teeth were
donated by 458 children aged 7-10 years in Duisburg, Germany, an industrial city with airborne
lead  concentrations  between  1.5  and 2.0  (jg/m3.   Two extreme  exposure  groups were formed,  a
low-lead  group  with  2.4 ug/g mean  tooth lead  level  (n =  26) and another,  high-lead group with
7  ug/g mean  tooth lead  level  (n  = 16).  These groups were matched  for age, sex, and father's
occupational status.   The two groups did  not  differ significantly on confounding covariates,
except that  the high-lead group showed more perinatal  risk factors.  Parental IQ and quality
of  the home  environment were not  among the 52  covariables examined.  The  authors  found a mar-
ginally  significant  decrease (p <0.10) of  5-7  IQ  points  and  a  significant decrease  in percep-
tual-motor integration  (p <0.05),  but no significant differences  in hyperactivity as measured
by  the Conners  Teachers' Questionnaire administered during  testing.  As with  the Yule et al.
(1981) study,  the inadequacy of  statistical or other control  for background  social variables
and  parental IQ  (as well  as  group  differences  in perinatal factors)  weaken this study; the in-
vestigators  cautioned against interpretation  of their  results  as evidence for low-level  lead
exposure  effects  in  the  absence  of further,   confirmatory  results  from  larger, better  con-
trolled  studies  (such as those conducted  by them elsewhere as described  below).
      In  their  second study, Winneke  et al.  (1983)  evaluated 115  children (X  age =9.4  years)
living  in the  lead  smelter  town  of Stolberg,  Germany.   Tooth  lead (X = 6.16  ppm, range =
2.0-38.5  ppm)  and blood lead levels  (X  =  13.4 ug/dl; range = 6.8-33.8  ug/dl)  were signifi-
cantly  correlated  (r =  0.47;  p <0.001)  for  the  children studied.   Using stepwise multiple
regression  analysis, the authors  found  significant (p <0.05)   or marginally  significant  (p
<0.10)  associations  between tooth  lead  levels and measures of perceptual-motor integration,
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reaction-time  performance,  and four behavioral rating  dimensions,  including  distract!bility.
This  was true  even  after  taking  into  account  age,   sex,  duration of  labor  at birth,  and
socio-heredity background as covariates.   However, the proportion of explained variance due to
lead  never  exceeded 6 percent for  any of  these outcomes, and no  significant  association  was
found between  tooth lead and WISC  verbal  IQ  after the effects of socio-hereditary background
were eliminated.
     A third  study  by Winneke et al. (1984) evaluated neuropsychologic functioning and neuro-
physiological  parameters  for 122  children (aged  6-7  yr) living in the  Nordenham,  FRG area.
Performance on  a  variety of neuropsychologic tests (shortened form of the Hamburg-Wechsler IQ
test; reaction-behavior  and  reaction-time  tests,  etc.) was evaluated in relation to  both con-
currently sampled blood  lead values (X =  8  ug/dl;  max.  = 23 ug/dl) and  umbilical  cord blood
lead  levels  (max. = 31 ug/dl).  A  variety of potentially confounding factors (such  as  socio-
hereditary variables, pre- and postnatal  risk factors,  etc.) were also assessed and taken into
account in a series  of stepwise multiple  regression analyses in which the effects of  confound-
ing  factors  were successively eliminated  and  the  effects of lead then  checked  for signifi-
cance.  No significant associations (at  p <0.05) were  found  between either umbilical  cord or
current  blood  lead  levels   and  verbal,  performance,  or  total   IQ  scores estimated from  the
Hamburg-Wechsler  subtests  (only  the  correlation  for performance  IQ with  current blood lead
level reached  p <0.10).   On  the  other  hand,  much larger  and highly  significant correlations
were  found  between  socio-hereditary factors  and  all  three types of IQ  scores.   The investi-
gators remarked on  the  heavy dependence  of the  IQ measurements  on the social  environment and
noted that, as in their prior large-scale study (Winneke et al.,  1983),  it was not possible to
convincingly show a lead-dependent decrease in intelligence.   Nor were any lead effects found
on the Goettinger shape  reproduction test of psychomotor performance or for various  reaction-
time measures.  Only  in  the case of reaction  behavior,  as indexed by increased errors  on the
Wiener (Vienna) serial stimulus reaction  test, were significant deficits in neuropsychological
functioning detected  at  the  low  exposure levels (<25-30 ug/dl)  evaluated in this study.  Cer-
tain  statistically  significant effects on  electrophysiological  measures of neurophysiological
functioning were also observed (as described below in Section 12.4.2.2.2.7).
     The  above  smelter area studies generally  do  not  provide much evidence for  cognitive or
behavioral deficits being associated with  lead exposure in non-overtly lead exposed  children,
except perphaps  for the  reaction-behavior deficits reported  by Winneke et al.  (1984).   The
lack of  convincing  evidence  for  IQ deficits  at the  blood lead levels (generally 15-30 ug/dl)
typifying the  pediatric  populations  studied  by Winneke  comport well with  the same type of
findings reported by British investigators (Yule;  Smith; Harvey)  for general population groups
with  similar lead  exposure  ranges.   At the  same time,   the  possibility of small  neuropsy-
chologic deficits being  associated with  lead exposure  in  apparently  asymptomatic children at
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the exposure levels  studied  cannot  be completely ruled out,  given  the overall  pattern of re-
sults obtained with  the  cross sectional  study designs employed by Winneke and the British in-
vestigators.  Small, 1-2 point differences in IQ seen in some of their studies between control
and lead exposure groups might in fact be due to lead effects masked by much larger effects of
socioeconomic factors, home  environment,  or parental IQ.   At the same time, the very small or
nil differences  in  IQ seen in these studies for children with blood lead levels mainly in the
15-30 ug/dl range suggest  that,  if  the IQ  decrements  are  in fact due to lead,  then it is ex-
tremely unlikely that any  IQ effects (of presumably even smaller magnitude) would be convinc-
ingly detectable at lower blood lead levels.
     12.4.2.2.2.4   Studies of neuropsychiatrically  disordered children.   Rather than starting
with  a  known lead-exposed  population and  attempting  to discover evidence of neurobehavioral
dysfunction, a  number of studies have first identified a population with some recognized dis-
order  and  then  looked  for   evidence  of elevated  lead exposure.   For example, a  series of
studies  by David et al. (1972;  1976a,b;  1977;  1979a,b;  1982a,b;  1983;  1985)  measured  lead
levels  in diagnosed hyperkinetic children  and  showed  an association between hyperactivity and
elevated  lead  levels.  However,  whether  a  disorder  such as  hyperactivity  is the effect or the
cause of  elevated lead exposure  is a difficult  issue to resolve.  It is possible, for example,
that  hyperactive children might ingest  more  lead  than normal  children  because of a greater
incidence of  pica  or even because  they  stir up more  dust-borne  lead  by their activity.   How-
ever,  David  et al.  (1977)  reported that  blood lead  levels of hyperactive children  with a
probable  etiology  of an organic nature  were  lower  than  those  of  children with no apparent
cause (other than lead).  This finding suggests that hyperactivity does not necessarily result
in elevated lead exposure,  but  it  does  not rule out the possibility of a  third  factor causing
both  hyperactivity  and elevated blood lead levels  (see discussion of  Gittelman and  Eskenazi,
1983,  below).   Also, a  problem  common  to the  studies  in  question  is  the  lack  of adequate in-
formation on the  children's past exposure  to  lead,  particularly during preschool years  when
children  tend to be  at  greatest risk to higher exposure  levels.  As David et al.  (1976a)  have
acknowledged,   it  is difficult  to  establish  an etiological  relationship  between  lead  and
behavioral disorders on  the  basis of retrospective  estimations of lead exposure.
      A  recent  study by David et al.  (1983) appeared to  obviate some of the problems of the
correlational  approach  by  experimentally  manipulating  body lead  levels,  i.e., by  reducing
blood lead concentrations  through the administration of a  chelating agent, penicillamine.   The
objective was to determine  if decreases in body lead would be accompanied by  improvements in
children's hyperactive  behavior,  and in short,  this  was  essentially the  conclusion  drawn by
David and  his  colleagues.   In addition, the study  compared the effect of the chelating agent
with a therapeutic drug of known efficacy,  methylphenidate, and found the two treatments to be
 roughly equivalent in reducing symptoms of hyperactivity.
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     Although this  study  by David et al.  (1983)  was  in many respects well designed  and  exe-
cuted,  certain  problems  nevertheless cloud  its  interpretation.   As  noted by Needleman  and
Bellinger  (1984),  the number of  subjects  per treatment group was rather  limited  (maximum of
31)  and  quite unbalanced  due in  part to a high and disproportionate  subject  attrition  rate.
Subjects were particularly prone  to drop out  of the  placebo  group, and  this  imbalance  was
exacerbated  by  a "chance  preponderance" of  subjects assigned to  the  penicillamine  treatment
and  by  later reassignment  of  some placebo and methylphenidate subjects to the  penicillamine
group.   Questions  might  also be  raised  concerning  the  appropriateness  of  the  statistical
treatment  of data  by  David et al.  (1983).   For  example,  multivariate  analysis  of  variance
(MANOVA) would  seem  to be more appropriate than  separate  ANOVAs  and multiple  t-tests applied
to the  various  outcome measures  used to assess the  children's  behavior.   Use  of MANOVA  would
also  have  helped alleviate the problem  of regression  toward the  mean, which  in  this  case may
have  created the false impression that  "improvements"  in  behavior,  i.e.,  changes toward more
normal behavior, were due to an effect of the treatment.  Rutter (1983, p.  313) has also  noted
that  David's multiple  group comparisons  are  not as convincing as  an analysis  that would  util-
ize individual blood lead  and behavior scores (presumably, multivariate  regression analysis).
Finally, as  David  et al.  (1983)  themselves point out,  it is clear that lead could be  only one
of several etiological factors in the causation of hyperkinesis or attention deficit disorders
in children  and that, at best, their findings pertain only to recognized  hyperactive children,
not to the general  population.
     An  attempt by Gittelman  and Eskenazi (1983) to  replicate  earlier  work  by David et  al.
(1972;  1977) was only  partly  supportive  of  the  letter's  findings.   A large  group of  hyper-
active  children (n =  103)  showed a trend (p =  0.06) toward higher chelated lead  levels in
their urine,  but a  clear-cut (p  = 0.02) elevation in  lead  levels was evident only  in paired
comparisons  with  33 nonhyperkinetic  siblings.  As Gittelman and  Eskenazi  (1983)  noted,  this
finding  raises  the  question of why the hyperactive children had higher lead levels than  their
siblings,  given that  they shared the same water,  air,  and home environment.   The possibility
of a third factor,  e. g.,  a metabolic difference that might affect the ability  to excrete lead
as well as the occurrence of hyperactivity, cannot be dismissed.
     A study of 98  Swedish children with various  minor neuropsychiatric  disorders (e.g.,  per-
ceptual-motor dysfunctions, speech disorders, attention deficit problems)  found no correlation
between  the  children's disorders and their  tooth  lead levels (Gillberg  et al.,  1982).   How-
ever, comparing the  10 highest and  10 lowest  lead-burdened  children did  reveal  a significant
difference in a clinical measure  of their mean reaction times.
     Youroukos  et  al.   (1978)  compared  the blood  lead as well  as  ALA-D  values  of  60  Greek
children with mental  retardation  of unknown etiology  against  30 mentally retarded  children
with  a  known etiology  and 30 normal  children.   The average values of the mentally  retarded
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patients were  significantly  different  from both of the  control  groups in two regards:   blood
lead  "level  was higher (30 pg/dl versus 21 (jg/dl  in  both control groups) and,  in  14 patients
with  elevated  U 40  ug/dl)  blood  lead  levels,  ALA-D  activity  was  significantly  lower.
Although pica was noted to be common in both groups of mentally retarded children,  no child in
the study was known to have ever been lead-poisoned.
     Work in  Scotland  has provided information tending to link prenatal lead exposures to the
later development of  mental  retardation.   Beattie et  al.  (1975) identified 77 retarded chil-
dren and 77 normal children matched on age, sex, and geography.  The residence during the ges-
tation of the  subject was determined, and a  first-flush morning sample of tap water was ob-
tained from  the  residence.   Of 64 matched pairs,  no  normal  children were  found to  come from
homes served with water  containing high lead levels (>800 ug/liter), whereas 11 of the 64 re-
tarded children  came  from homes served with such high-lead water.  The authors concluded that
pregnancy in  a home with high  lead  in  the water supply increases by a factor of 1.7 the risk
of bearing a retarded child.   In follow-up work, Moore et al. (1977) obtained lead values from
blood samples  drawn during  the second week  of life  from children studied by  Beattie  et al.
The samples had been obtained as part of routine screening for phenylketonuria and kept stored
on  filter  paper.   Blood  samples  were available  for 41  of the retarded and  36 of the normal
children in the original study by  Beattie  et al.  Blood  lead  concentrations in  the retarded
children were significantly  higher than values  measured in  normal  children:   the  mean for
retardates  was  1.23  ±  0.43  umol/liter (25.5  ±8.9  ug/dl)  and for  normals was  1.0  ± 0.38
umol/liter  (20.9 ± 7.9  ug/dl).  The  difference  in lead  concentrations was  significant (p =
0.02) by the Mann-Whitney test.
     These  latter  two studies  suggest that  lead exposure  to  the fetus during  the critical
period of brain development  may cause perturbations  in  brain organization that are expressed
later in mental  retardation  syndromes, and they raise for careful scrutiny the issue of post-
natal risks  associated with  intrauterine exposure to  lead.   Long-term prospective studies of
the type described  next are beginning to produce results which address that issue.
     12.4.2.2.2.5    Prospective Studies of Neurobehavioral Effects of In-Utero or Early Post-
natal Lead Exposures.  During recent years a number of prospective studies have been initiated
in  the  United States  and abroad  (Europe,   Australia,  etc.).   These studies  emphasize the
following:    (1)  the documentation  of lead exposure histories during pregnancy, at birth, and/
or  postnatally well  into later years  of  childhood;  and  (2)  the evaluation of relationships
between such lead exposures and delays in early postnatal  physical or  neurological development
and,  also,  subsequent alterations  in normal  neuropsychological and neurophysiological  func-
tions.  Progress  in a number of these  studies was discussed at  the Second International Con-
ference on  Prospective  Lead  Studies held  in April,  1984 (Bornschein and Rabinowitz,  1985).

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Initial  results  have  been obtained from two  of  these studies and are of  particular  interest
here.
     As part of  a longitudinal  study of early developmental effects  of lead,  Bellinger et al.
(1984a) administered  Bayley  Scales  of Infant Development at age 6 months to infants born at a
Boston  hospital.   The infants were  classified  into three groups according to  umbilical  cord
blood lead levels obtained at birth:  low (X = 1.8 u/dl);  middle (X =  6.5  M9/dl); and high (X =
14.6 ug/dl; none  exceeded 30 ug/dl).   Multiple  regression  analyses  indicated that the "high"
cord blood-lead  levels were  significantly  associated with lower covariance-adjusted scores on
the  Bayley Mental  Development  Index,  but scores on the Psychomotor Development Index  were not
related to cord  blood-lead levels.   Infant blood-lead levels  sampled  at 6 months  of  age were
not  associated with  scores on  either the Mental  or Psychomotor Development Index.   These data
were  interpreted  by  Bellinger et  al.  (1984a, 1985)  as  being compatible  with  the hypothesis
that  low  levels  of   lead  delivered  transplacentally to  the  fetus are  toxic to  the  newborn
infant.  However,  although the  results suggest that jrn utero exposure may result in delays in
early development  during  the first 6 months  postnatally, the  results  do not  allow estimation
of the persistence of the observed delays in postnatal neurobehavioral  development.
     Dietrich et  al.  (1985a) also  recently reported initial results  emerging  from  a long-term
prospective study  of infants born  in Cincinnati,  Ohio.   The  Bayley Mental Development Index
(MDI), Psychomotor Development Scale (PDS), and Infant Behavior Record (IBR) were administered
at 3, 6,  12,  and 24 months to infants not born at significant biological risk due  to  non-lead
factors (such as  low  birth weights, etc.).  The Home Observation for Measurement of the Envi-
ronment (HOME) scales (Caldwell  and Bradley, 1979) were used to assess and statistically con-
trol for  relevant  factors in the rearing  environments of the infants, and blood samples were
obtained  at  birth (umbilical cord blood),  10 days, and every three months thereafter.   Geo-
metric  mean  blood lead  levels  increased  from  6.11 ug/dl  at  3 months  to 14.87  ug/dl  at 12
months  and included  maximum values of 28,  33,  55, and 46 ug/dl  at  the  3, 6,  9 and  12 month
sampling points.   Based  on regression analyses between blood lead values at those  time points
and  MDI  scores  at  3, 6,  and 12 months,  only an  unadjusted negative  lag  correlation between
blood levels at  3 months and MDI at  6 months was  significant;  but  that correlation  was sub-
stantially reduced and no longer significant after adjustment for HOME scores.   Free  erythro-
cyte protoporphyrin levels at 6 months were significantly correlated  to 6-month MDI scores and
remained  so  after correction for  HOME scores.   As for  IBR data, only  "Sensory Interest" at
12 months  was  significantly negatively  correlated with  6  or 12 month  blood  lead levels (at
p <0.05 and p  <0.01,  respectively).   The  lag correlation between 6  month blood leads  and 12
month  IBR  "Sensory Interest" was  not significant after adjustment  for HOME  scores,  but the
correlation with  12 month blood  leads remained  significant  after  adjustment  for HOME scores.

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The investigators concluded,  based  on these initial results,  that  low to moderate lead expo-
sure during  the first year  of  life  has only  a  small  impact (if any)  on  early sensorimotor
development.
     (More recent significant  results from these other longitudinal  studies  are reviewed and
assessed in the Addendum to this document.)
     12.4.2.2.2.6     Studies of association of neuropsychologic effects and hair lead levels.
Several studies have reported significant associations between hair lead levels and behavioral
or cognitive testing endpoints (Pihl and Parkes, 1977; Hole et al., 1979; Hansen et al., 1980;
Capel et al., 1981; Ely et al., 1981; Thatcher et al., 1982; Marlowe et al., 1982, 1983, 1985;
Marlowe and  Errera,  1982).    Measures of hair  lead are  easily contaminated by external expo-
sure and  are generally questionable in terms of accurately  reflecting  internal  body burdens
(see Chapter 9).  Such  data, therefore,  cannot  be credibly  used to  evaluate relationships
between absorbed lead and nervous system effects and are not discussed further here.
     12.4.2.2.2.7   Electrophysiological  studies of  lead  effects  in  children.    In  addition to
psychometric and behavioral  approaches,  electrophysiological  studies of lead neurotoxicity in
non-overtly  lead-intoxicated  children have been conducted.  One such  study (Thatcher et al.  ,
1984)  reported  significant effects  on  various  measures of auditory  and visual evoked poten-
tials  in  lead-exposed children, but  the only measure of  lead exposure  was hair lead, which,
as previously noted, is not a suitable index of lead exposure.
     Burchfiel  et  al.  (1980)  used computer-assisted spectral analysis of a standard EEC exam-
ination  on 41  children  from the  Needleman et al.  (1979)  study and  reported significant EEC
spectrum  differences  in  percentages of  alpha and  low-frequency  delta activity in spontaneous
EEGs of the high-lead  children.  Percentages  of alpha and  delta  frequency  EEG activity and
results  for  several  psychometric and behavioral testing variables  (e.g., WISC-R  full-scale IQ
and  verbal  IQ,  reaction  time  under  varying  delay,  etc.)  for  the  same  children  were then
employed  as  input variables (or  "features")  in  direct and  stepwise  discriminant analyses.  The
separation   determined  by  these  analyses   for  combined psychological   and  EEG  variables
(p <0.005) was  reported to be  strikingly better than the separation of  low-lead from high-lead
children  using  either psychological  (p  <0.041)  or  EEG (p  <0.079)  variables  alone.  Unfortun-
ately,  no dentine  lead or blood lead values were  reported for  the specific  children  from the
Needleman et al. (1979) study who  underwent the EEG evaluations  reported  by Burchfiel  et al.
(1980).   Lead-exposure  levels associated with  the  observed EEG  effects  would appear  likely to
fall within  the same  broad 30-50 ng/dl  blood lead range estimated  earlier  for the Needleman IQ
deficit observations.
     Guerit  et  al.  (1981) examined  79  11-year-old  children attending three  different schools
in  the vicinity of a  lead  smelter and  presenting  blood  lead levels  up to 44 |jg/dl  (averaging

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less than 30 ug/dl).  Children from two distant urban and rural schools served as controls.  A
neurophysiological  function  score  for each child was based on measures of EEGs, visual evoked
potentials,  brainstem  auditory  evoked  potentials,  and  eye movements.   Neurophysiological
scores  were negatively  correlated  (p <0.05  by  Spearman  rank correlation  coefficient)  with
blood  lead  and FEP  levels for  the  children from  one  of  the  smelter area  schools,  but the
authors  attributed  this finding to  the  inclusion  of four  children who were  left-handed or
suffering  from external ear  pathology.   Chi-square  tests  of neurophysiological  scores  as a
function  of blood  lead  or FEP  groupings  based  on  the  total study population  were  all  non-
significant.   Note  that  comparatively low power nonparametric statistical tests were employed
in  this  study  because of the qualitative  or  ordinal  nature of the data.   However, the use of
more detailed  quantitative measures  of neurophysiological function would have enabled the in-
vestigators  to employ more  powerful  parametric  statistics, with  possibly  different  outcomes
from their analyses.
     The  relationship between low-level  lead exposure and neurobehavioral function (including
electrophysiological  responses)  in  children aged  13-75 months  was extensively  explored in
another  study,  conducted at  the University  of  North Carolina in  collaboration  with  the  U.S.
Environmental  Protection Agency.   Psychometric  evaluation revealed a significant lead-related
IQ  decrement at the time of  initial  evaluation (Schroeder et al., 1985),  as noted previously.
No  relationship between  blood lead and hyperactive behavior (as indexed by standardized play-
room measures  and parent-teacher rating  scales) was observed in these children (Milar et al.,
1981a).  On the other hand, electrophysiological assessments, including analyses of slow cort-
ical potentials during  sensory  conditioning (Otto et al.,  1981)  and EEG spectra (Benignus et
al., 1981),  did provide  evidence of CNS effects  of  lead in the same children.   A significant
linear  relationship  between  blood lead  (ranging from  6 to  59  ug/dl) and  slow wave voltage
during  conditioning trials  was  observed  (Otto et  al.,  1981), as  depicted in  Figure  12-3.
Analyses  of  quadratic and  cubic  trends,  moreover, did not  reveal  any evidence of a threshold
for this  effect.  The slope of the blood  lead  x slow wave  voltage  function,  however, varied
systematically with age.   No  effect  of blood lead on EEG power spectra or coherence measures
was observed,  but the  relative  amplitude of  synchronized EEG between left  and right hemis-
pheres  (gain spectra) increased relative  to blood  lead levels  (Benignus  et al.,  1981).   A
significant  cubic trend  for gain between the left and  right parietal  lobes was  found with a
major  inflection point  at  15 ug/dl.   This finding suggests  that  EEG gain is altered at blood
lead levels as low as 15 ug/dl,  although  the clinical and functional  significance of this  mea-
sure has not been  established.
     A  follow-up  study  of  slow cortical  potentials  and  EEG spectra in a subset (28  children
aged 35-93 months) of the original  sample was carried out two years later (Otto et al., 1982).

                                           12-104

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    (9
    UJ
    I
 30

 20

 10

  0

-10

-20

-30

-40



 10


  0


-10


-20


-30
 20


 10


   0


-10


-20
                                       MONTHS
              I    I    1    I    I    1    I
                                                    (b)
AGE. months
•  1223
•  2435
A  3647
                  I
                      I
                          I
                      \   I
                    1    I
\    I
  (el'
                  o 48 59
                  O 6075
              I    I    I
                 I
                                          J_
              5   10   15  20  25  30  35   40  45  50  55

                            PbB LEVEL, pg/dl

Figure 12-3.  (a) Predicted slow wave voltage and 95% confidence
bounds in 13- and 75-month-old children as a function of blood
lead level, (b) Scatter plots of slow wave data from children aged
13 to 47 months with predicted regression lines for ages 18, 30,
and 42 months,  (c) Scatter plots for children aged 48 to 75
months with predicted regression lines for ages 54 and 66 months.
These graphs depict the linear interaction of blood lead and age.

Source: Ottoetal. (1981).
                                12-105

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Slow wave voltage during sensory conditioning again varied as a linear function of blood lead,
even though  the mean  lead  level had  declined by  11 ug/dl  (from 32.5 ug/dl  to  21.1 ug/dl).
Although the EEG  gain  effect did not persist, the similarity of slow wave voltage results ob-
tained  at  initial and  follow-up assessments  suggests  that the observed  alterations  in this
parameter of  CNS function were  persistent,  despite a significant decrease in  the  mean blood
lead level  during the two-year interval.
     In a five-year follow-up study on a subset of the same children, Otto et al.  (1985) found
that slow wave  voltage varied as a  function  of  current blood lead level  during active condi-
tioning, but not during the passive conditioning test used in earlier studies.   In the passive
test, a  tone was  paired with a short blackout of a silent cartoon.  The active test was simi-
lar  except  that children pressed a  button to terminate the blackout and  resume  the cartoon.
Although the brain response  elicited by the  active  test is  greater than that produced by the
passive  test,  the active test  cannot  be performed reliably by children  under five years  of
age.
     In  addition  to  the experimental conditioning  tests,  Otto et al.  (1985)  used  two clini-
cally validated  measures of  sensory function, the  pattern-reversal  visual evoked potential
(PREP)  and  the  brainstem auditory  evoked  potential (BAEP).   Exploratory analysis  of PREPs
revealed increased amplitude  and decreased  latency of certain components as a linear function
of original  blood lead levels.  Although these results were contrary to predictions, the find-
ings  are consistent  with the  results  of  Winneke  et  al.  (1984),  who found  an  association
between  increased blood  lead  level  and decreased latency in the primary positive  component of
PREPs in children.   BAEP results of the five-year  follow-up study also indicated significant
associations between original  blood lead levels  and  increased  latencies of  two  components
(waves III  and V), indicative of auditory nerve conduction slowing.
     Otto and his coworkers  (Otto,  1986; Robinson et al., 1985) recently reported the results
of  a replication study  with  an independent group  of children 3 to 7 years old.   Blood lead
levels ranged from 6 to 47 ug/dl at the time of testing.   Psychometric data  from  this study
(Schroeder and  Hawk,  1986)  have been reviewed above.  Sensory conditioning was limited to the
passive test due to the age range of the children.   Contrary to earlier findings (Otto et al.,
1981, 1982), slow wave voltage  did not  vary  with  blood lead levels.   Differences between the
two  groups studied,  however,  may have contributed to the discordant results.   Children in the
earlier  studies  were somewhat  younger  (1-6   versus  3-7 years) and were exposed  by different
routes (secondary occupational exposure versus lead paint and contaminated soil) than children
in the  replication study (see review by Otto, 1986).  Until  further studies are undertaken to
clarify the inconsistent  slow wave  results,  earlier  findings  must be interpreted cautiously.
                                           12-106

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     Inconsistencies in PREP and  BAEP  results between the five-year follow-up and replication
studies were  also found.   Only  one PREP  amplitude  measure varied  systematically with  blood
lead levels  in the  replication  study, and this  was  in the opposite direction  from  previous
findings.   BAEP results of  the replication study were considerably more complex and  only par-
tially consistent with  the  five-year follow-up study.  Several  BAEP latency measures  showed a
curvilinear relationship  to  maximal blood lead levels, whereas a  simple  linear relationship
was observed in the earlier study.  That is, BAEP latencies in the replication study  decreased
as blood  lead  levels rose from 6 to 25 ug/dl, but increased at  higher  PbB levels.   The des-
cending limb  of  this  curve  paralleled the  findings  of  Winneke  et al. (1984),  who  observed
faster peripheral  nerve  conduction  velocities as well  as decreasing  latency  in the primary
positive PREP component of children with blood lead levels up to 23 ug/dl.   On the other hand,
the  ascending  limb  of the  BAEP latency  curve was  consistent  with the  five-year  follow-up
results.   Moreover,  the  I-V  interpeak latency, a measure of  central transmission time in the
auditory  pathway,  increased  linearly with  increasing blood lead  levels   in  the replication
study.   In  addition, hearing threshold, a  reflection  of  peripheral auditory system function,
increased directly  with  lead levels.  Although hearing threshold did not vary with blood lead
level  in  the  five-year  follow-up study  (Otto et al., 1985), this finding bears further in-
vestigation in  view of other reports  suggesting  impaired auditory processing in lead-exposed
children  (de la Burde and Choate, 1975; Needleman et al., 1979).
     In  summary,  these  electrophysiological  studies  provide   suggestive  evidence   of  lead-
related effects  on  CMS function  in children  at blood  lead levels considerably below 30 ug/dl,
but  inconsistent findings across studies  require  clarification.   Linear  dose-response rela-
tions  have  been observed in slow-wave  voltage during conditioning  (Otto   et al., 1981, 1982,
1985),  BAEP latency  (Otto  et al.,  1985), PREP  latency  (Otto et  al.,  1985;  Winneke et al.,
1984), and  PREP amplitude (Otto, 1986;  Otto  et aT.,  1985a), although the  specific components
affected  and  direction of effect varied across studies.   Sensory evoked potentials,  in parti-
cular,  hold considerable promise as  sensitive,  clinically  valid nervous  system measures un-
affected  by social   factors that  tend  to confound traditional psychometric  measures  (Halliday
and  McDonald,  1981;  Prasher  et al.,  1981).  BAEPs,  for instance,  are not altered by changes  in
attention or  level  of consciousness.    Reliable  BAEPs can  be  recorded in  (sedated)  children
between the ages  of one and  five, the  most vulnerable period  for lead poisoning  as well  as  the
most difficult period for most  types  of neurobehavioral  testing.   The  current  electrophysio-
logical  evidence concerning lead exposure  and brain  function  in  children,  however, is  too
fragmentary to draw any firm conclusions.   The use  of evoked  potential  measures  in prospective
pediatric lead studies would  provide  a very  useful adjunct to  other neurobehavioral  tests  and
would  help to  resolve current  uncertainties regarding the neurobehavioral threshold of  lead
toxicity.
                                            12-107

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     The adverse  effects  of lead on peripheral  nerve  function  in children remain to be  con-
sidered.   Lead-induced peripheral neuropathies,  although  often  seen in adults  after  prolonged
exposures,  are  rare in children.  Several articles  (Anku  and Harris,  1974; Erenberg et  al.,
1974; Seto and  Freeman,  1964),  however,  describe case  histories of children with  lead-induced
peripheral  neuropathies,  as indexed by electromyography,  assessment of  nerve conduction  veloc-
ity, and  observation of  other  overt neurological  signs,  such  as  tremor and  wrist or  foot
drop.   Frank  neuropathic  effects  have  been observed  at blood  lead  levels  of  60-80 pg/dl
(Erenberg et  al., 1974).   In  one case  study (Seto and  Freeman, 1964), signs indicative  of
peripheral  neuropathy were  reported  to  be associated with blood lead values of 30 ug/dl;  how-
ever, lead  lines  in long bones  suggested  probable  past  exposures leading to peak blood  lead
levels at least as  high  as 40-60 ug/dl  and  probably in  excess  of 60 (jg/dl  (based on the  data
of  Betts  et al., 1973).   In all  of these  case  studies,  some, if not complete, recovery  of
affected motor functions  was reported after treatment for lead poisoning.   A tentative associ-
ation has also  been hypothesized between sickle cell disease and increased risk of peripheral
neuropathy as  a consequence of childhood  lead exposure.   Half of the cases reported (10  out  of
20)  involved  inner-city   Black  children, several with  sickle cell  anemia  (Anku  and Harris,
1974; Lampert  and Schochet, 1968;  Seto  and  Freeman, 1964;  Imbus et al., 1978).  In summary,
evidence exists  for  frank peripheral  neuropathy  in  children,  and  such  neuropathy can  be
associated with blood  lead  levels  at least as  low  as  60 ug/dl  and,  possibly,  as  low as 40-60
ug/dl.
     Further evidence for lead-induced peripheral  nerve dysfunction in  children is provided  by
two  studies by Feldman  et  al.   (1973a,b,  1977) of  inner  city  children  and  from a  study  by
Landrigan et  al.  (1976)   of children living  in close proximity  to a  smelter  in Idaho.  The
nerve conduction  velocity (NCV)  results  from the latter  study are presented in Figure 12-4  in
the  form  of a  scatter  diagram  relating  peroneal  nerve conduction  velocities to blood  lead
levels.   No clearly abnormal conduction velocities were  observed,  although a statistically
significant negative  correlation was found  between peroneal NCV and  blood lead levels  (r =
-0.38, p <0.02  by one-tailed t-test).   These results,  therefore,  provide evidence for  signi-
ficant slowing of nerve  conduction  velocity  (and,  presumably, for advancing peripheral  neuro-
pathy as  a  function  of  increased blood lead levels), but do not allow  clear  statements re-
garding a threshold  for pathologic slowing of NCV.
     In a recent  study mentioned earlier,  Winneke et al.  (1984)  evaluated  neurophysiological
functions as  well as  neuropsychologic performance  in  children  from Nordenham, FRG.  Results
from a standard neurological examination  and  sensory nerve conduction velocities of the  radial
and median nerves were analyzed in relation to concurrent blood  lead values  and umbilical  cord
blood lead  levels  sampled approximately  six  years earlier.   Contrary  to expectations, in-
creasing conduction  velocities  for  radial  and median nerves were found to be significantly
                                          12-108

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!
    88.00
    82 90
    77 GO
    72.40
t   6720
8
o
    6200
Q   56.80
    51.60
    46.<
    41.20
    36.00
~~|	1	1	1	1	1      I	
 Y (CONDUCTION VELOCITY) = 54.8 - .045 x (BLOOD LEAD)

(r = -0.38) (n = 202)
   •   • * •  M*     *  •     •*
  %7JJ  •*w^**  •** *
                i      i

                            i
         0     15    30    45     60    75    90    105   120   135    150

                                  BLOOD LEAD. M9/dl


 Figure 12-4. Peroneal nerve conduction velocity versus blood lead level, Idaho,
 1974.

 Source: Landrigan et al (1976).
                                    12-109

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associated  with current blood  lead levels  (at  p <0.01 and  <0.10,  respectively).   As  noted
above,  visual  evoked potentials  showed  a significantly  decreased latency  in  one  component,
which  suggested more rapid conduction  in  the visual pathway, consistent with  the  peripheral
nerve  conduction  findings.  Somatosensory  evoked potentials showed no significant effect;  nor
were  associations  found  between any of the  electrophysiological measures  and  cord  blood lead
levels  or  any  of a number of socio-hereditary background  variables  (the latter of  which were
strongly related to neuropsychologic outcome results).
     The lead-associated increases  in  nerve  conduction observed by Winneke  et  al.  (1984)  for
children with  blood lead  levels  below 25-30 ug/dl  differ from previously  noted findings  of
slowed  NCVs being  associated  with increasing blood  lead values  above 30 ug/dl.   However,  the
apparently paradoxical  findings were noted by the investigators as  being consistent  with  those
of Englert  (1978),  who  similarly  found an increase in the motor NCV  of the median nerve  among
lead-exposed children in Nordenham.  Winneke et  al.  (1984) nevertheless cautioned  that  these
findings still  require  experimental confirmation  before  a bi-phasic effect of  lead on  peri-
pheral nervous functions can be assumed.

12.4.3  Animal Studies
     The following  sections  focus  on  recent experimental  studies of lead  effects on behav-
ioral, morphological, physiological, and  biochemical parameters of nervous system development
and function  in laboratory animals.   Several basic areas  or issues are addressed:   (1) behav-
iorial toxicity,  including the  question  of critical  exposure  periods for concurrent induction
or later expression  of  behavioral  dysfunction in motor development,  learning performance,  and
social  interactions; (2) alterations in  morphology,  including synaptogenesis,  dendritic  deve-
lopment, myelination, and fiber tract formation;  (3)  perturbations  in various electrophysiolo-
gical  parameters, e.g.,  ionic  mechanisms  of neurotransmission or  nerve  conduction  velocities
in  various tracts;  (4)  disruptions of biochemical  processes such  as energy metabolism  and
chemical neurotransmission; (5)  the persistence or reversibility of the above types  of effects
beyond  the  cessation of external  lead exposure;  and (6)  the  issue of "threshold"  for neuro-
toxic effects of lead.
     Since the initial  description of lead encephalopathy  in the developing rat (Pentschew and
Garro,  1966),  considerable effort  has  been made  to  define more  closely the extent  of nervous
system  involvement  at  subencephalopathic  levels  of  lead  exposure.  This  experimental effort
has focused primarily on exposure of the  developing organism.   The  interpretation  of a  large
number of  studies  dealing  with  early iji vivo exposure  to  lead has,  however, been made diffi-
cult by variations  in certain  important experimental design factors  across available studies.
     One of  the more notable  of  the experimental shortcomings  of some studies  has been  the
occurrence  of  undernutrition  in  experimental  animals   (U.S.  Environmental  Protection Agency,
                                          12-110

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1977).   Conversely, certain  other  studies  of lead neurotoxicity  in  experimental  animals have
been confounded  by the  use  of  nutritionally  fortified diets,  i.e.,  most  commercial  rodent
feeds (Michaelson,  1980).   In  general,  deficiencies of certain  minerals  result  in increased
absorption of lead, whereas excesses of these minerals result in decreased uptake (see Chapter
10).  Dietary mineral  and  vitamin  components are known to alter certain neurotoxic effects of
lead (Woolley and Woolley-Efigenio, 1983).   Commercial feeds may also be contaminated by vari-
able amounts of  heavy metals,  including as much as 1.7 ppm of lead (Michaelson, 1980).   Ques-
tions have  also  been  raised about possible nutritional confounding due to the acetate radical
in the lead acetate solutions often used as the source of lead exposure in experimental  animal
studies (Barrett and Livesey, 1982).
     Another important factor that varies among many studies is the route of exposure to lead.
Exposure  of  the  suckling animal via the dam would appear to be the most "natural" method, yet
may  be  confounded by  lead-induced  chemical  changes  in milk composition.   On  the other hand,
intragastric gavage  allows  one  to determine  precisely the dose and  chemical  form of admin-
istered lead, but  the procedure is quite stressful  to the animal and does not necessarily re-
flect the actual  amount of  lead absorbed  by the gut.  Injections of lead salts  (usually per-
formed intraperitoneally) do not mimic natural exposure routes and can be complicated by local
tissue calcinosis  at  the site of repeated injections.
     Another variable in  experimental  animal  studies  that  merits  attention concerns species
and strains of  experimental  subjects  used.  Reports by Mykkanen  et  al.  (1980) and  Overmann et
al.  (1981)  have  suggested that  hooded rats  and  albino  rats may differ  in their sensitivity to
the toxic effects  of  lead, possibly because  of differences in  their  rates of maturation and/or
rates of  lead  absorption.   Such differences may account  for variability of  lead's  effects and
differences  in exposure-response relationships between  different  species as  well.
     Each of the above factors  may  lead to widely  variable internal  lead  burdens  in the  same
or  different species  exposed to roughly comparable  amounts of lead, making  comparison and in-
terpretation  of  results  across studies difficult (Shellenberger,  1984).   The force of  this
discussion,  then,  is  to emphasize  the importance  of measurements of  blood  and tissue concen-
trations  of lead  in  experimental  studies.   Without  such  measures, attempts  to  formulate dose-
response  relationships are  futile.   This  problem is  particularly  evident in later sections
dealing with the morphological, biochemical,  and  electrophysiological  aspects of  lead  neuro-
toxicity.   Jji vitro studies  reviewed  in  those  sections,  in  contrast  to iji  vivo  studies,  are  of
limited  relevance in dose-response terms.  The in  vitro  studies,  however, provide valuable
information on basic  mechanisms underlying the neurotoxic effects of lead.
     The  following sections  discuss and  evaluate the most recent studies of nervous system in-
volvement at subencephalopathic exposures  to  lead.   Most of  the older studies  are reviewed in

                                           12-111

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the  previous  Air Quality  Criteria  Document for  Lead (U.S.  Environmental  Protection  Agency,
1977).
12.4.3.1    The Behavioral Toxicity of Lead:   Critical Periods for Induction and Expression of
Effects.  The  perinatal  period  of  ontogeny has  been generally recognized as  a  particularly
critical time  for the  initiation  of neurobehavioral  pertubations  by exposure to  lead  (U.S.
Environmental  Protection  Agency, 1977;  Reiter,  1982; Kimmel,  1984).   This view is based in
part  on the metabolic  characteristics  of young  organisms,  which  show  comparatively  greater
absorption  and retention  of lead  (see  Chapter  10).   In  addition,  a  number of  behavioral
studies have compared the effects of lead exposure at different times  during ontogeny and have
often found  effects  associated  only with perinatal exposure (e.g.,  Brown,  1975; Brown  et al.,
1971; Padich and Zenick, 1977; Shigeta et al.,  1977; Snowdon, 1973).
     On the  other hand,  several  studies have  demonstrated that alterations  in  behavior can
result  from exposure after weaning or maturation in rats  (Angell and Weiss,  1982;  Bushnell and
Levin,  1983;  Cory-Slechta and  Thompson, 1979; Geist and Mattes,  1979;  Geist et  al.,  1985;
Kowalski et al.,  1982;  Lanthorn and Isaacson,  1978; McLean et al.,  1982;  Nation et  al.,  1982;
Ogilvie and  Martin,  1982; Shapiro  et al., 1973).   Similar findings have been  noted in  adult
subjects of other species, including pigeons (Barthalmus  et al., 1977; Dietz et al., 1979) and
fish (Weir and Mine, 1970).
     The  fact  that  late  developmental  exposure  to  lead  can induce  behavioral  effects  in
animals does not  mean,  of course,  that early exposure is less effective or important.   As the
following sections will  show,  the  toxic effects  of  lead  may be induced at various stages of
life, with  the expression of  these effects following closely or,  in some cases,  after con-
siderable delay.
12.4.3.1.1   Development of motor function and reflexes.   A variety  of methods  have been used
to assess the  effect of lead on the ability of experimental animals to respond appropriately
either  by well-defined  motor responses  or gross  movements,  to a  defined stimulus.   Such res-
ponses  have  been  variously described as reflexes,  kineses,  taxes,  and "species-specific" be-
havior patterns.   The air righting reflex, which refers to the ability to orient properly with
respect to  gravity while  falling through  the  air and to  land on  one's feet,  is only  one of
several commonly  used developmental markers  of  neurobehavioral  function  (Tilson  and  Harry,
1982).  Overmann  et  al.  (1979)  found that development of this particular reflex was slowed in
rat pups exposed to lead via their dams (0.02 or 0.2 percent lead acetate*  in the dams'  drink-
ing water).   However, neither the auditory startle reflex nor the ability to hang suspended by
the front paws was affected.
""Concentrations are presented here as originally reported by authors.   Note that a 0.2 percent
 solution of lead  acetate  contains 0.1 percent lead.  Also,  for  comparative purposes,  a con-
 centration of 0.1 percent equals 1000 ppm.
                                          12-112

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     Grant et al.  (1980) exposed rats indirectly to lead iji utero and during lactation through
the mothers'  milk and, after weaning, directly through drinking water containing the same lead
concentrations their  respective  dams had been given.   In addition to morphological  and physi-
cal effects  [see  Sections 12.5,  12.6,  and 12.8  for  discussions of this work  as reported  by
Fowler et  al.  (1980), Kimmel  et al.  (1980),  Faith et al.  (1979), and  Luster  et al.  (1978)],
there were delays in the development of surface righting and air righting reflexes in subjects
exposed under  the  50- and 250-ppm lead conditions; other reflexive patterns showed  no effect.
Locomotor  development generally showed  no significant  alteration  due to  lead exposure,  but
body weight was significantly depressed for the most part in the 50- and 250-ppm pups.
     Rabe  et al. (1985)  used a similar experimental  paradigm  to evaluate developmental land-
marks  in  rat  pups  exposed via  their dams to a  0.5  percent lead  acetate solution.   Although
this  concentration  of  lead  was much  higher  than the drinking water  solutions  used  by Grant
et al.  (1980), Rabe  et al.   (1985)  found  no  apparent delays  in  the  development  of surface
righting  and  negative geotaxis reflexes, nor in  the age at which the pups' eyes opened.  Body
weight  of the pups  was reduced  slightly at birth,  but by postnatal  day  (PND) 30 the lead-
exposed  pups  had attained normal  average weight.  In comparing these  two studies,  it should
also  be noted that  the mean  blood lead  level  at PND 16 was  only  20 ug/dl  for pups exposed
indirectly to  2500 ppm lead by  Rabe  et  al.  (1985), as opposed  to a median of 35 ug/dl at PND
11  for pups  exposed  indirectly  to  50 ppm lead by Grant et al.  (1980).   These differences are
probably  attributable to the different diets  used in the studies (see Mylroie  et al., 1978).
     The  ontogeny of  motor function  in lead-exposed rat  pups was also  investigated by Overmann
et  al.  (1981).  Exposure was  limited to the period  from  parturition  to weaning and occurred
through adulteration  of  the dams' drinking  water  with lead  (0.02 or  0.2 percent  lead  acetate).
The  development  of swimming performance  was  assessed on alternate  days  from  PND 6 to  24.  No
alterations  in swimming ability were found.   Rotorod performance was  also tested  at PND 21,
30,  60,  90,  150, and  440.  Overall,  the  ability  to remain  on  a rotating  rod was significantly
impaired  (p  <0.01) at 0.2 percent  and tended to  be impaired (0.10 > p >  0.05)  at 0.02  percent
(blood lead  values were not  reported).   However, data for individual  days were statistically
significant only on  PND-60 and 150.   An  adverse effect of  lead exposure on rotorod  performance
at PND 30-70 was also  found  in an  earlier study  by Overmann (1977)  at a  higher exposure  level
of 30 mg/kg  lead  acetate by intubation  (average blood lead  value at  PND  21: 173.5 ± 32.0
ug/dl).   At blood  lead concentrations averaging 33.2  ± 1.4 ug/dl,  however,  performance  was  not
impaired.   Moreover, other studies  with  average  blood lead concentrations of  approximately 61
ug/dl  (Zenick et al.,  1979)  and 30-48 ug/dl (Grant  et  al.,  1980) have  not found  significant
effects of lead on  rotorod  performance  when tested  at  PND 21 and 45, respectively.   Compari-
sons  between studies  are  confounded by  differences  in  body weight  and age at time of testing
and by differences in speed  and size of  the rotorod apparatus  (Zenick et al.,  1979).
                                           12-113

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     Kishi et al.  (1983)  evaluated reflex development and motor coordination in male rats ex-
posed  to lead  acetate by  gavage  on  PND 3-21.   The air  righting reflex  was  significantly
delayed  in  all  three lead exposure  groups  (the lowest level producing an  average  blood lead
level of 59 ug/dl at PND 22).  The startle reflex showed no effect, and eye opening was accel-
erated  in the  lowest  exposure  group.   Rotorod performance at  PND 53-58  was  significantly
impaired  in the  highest exposure group  (average blood lead  level:   186 ug/dl at  PND 22).
Ambulation was  assessed at  PND 59-60 and  showed a high  degree of variability across the lead
exposure groups  (very  low or very high levels or movement); other measures of activity showed
no differences.   The effects on ambulation were not evident at PND 288-289.
     Delays in  the  development of gross activity in rat pups have been reported by Crofton et
al.  (1980)  and  by  Jason  and Kellogg (1981).   It  should  be noted that very  few studies have
been designed  to measure  the  rate  of  development of activity.   Ideally,  subjects  should be
assessed  daily  over the  entire  period of development in  order to detect any changes  in the
rate at  which a behavior pattern  occurs  and  matures.   In the study by Crofton et al.  (1980),
photocell interruptions by  pups  as they moved  through small  passageways  into an "exploratory
cage" adjacent to the home cage were automatically counted on PND 5-21.   Pups exposed i_n utero
through  the dams'  drinking  water  (200 mg/1 solution  of  lead chloride) lagged controls by ap-
proximately one  day in regard  to characteristic changes  in daily activity count levels start-
ing at PND  16.   (Blood lead concentrations at  PND 21 averaged 14.5 ± 6.8 ug/dl  for represen-
tative pups  exposed to  lead j_n  utero  and 4.8  ± 1.5 ug/dl  for controls.)   Another  form of
developmental  lag  in gross  activity around  PND 15-18,  as measured in an  automated activity
chamber, was reported  by  Jason and Kellogg (1981).  Rats were intubated on PND 2-14 with lead
at 25  mg/kg  (blood lead:  50.07 ±  5.33 ug/dl) and 75 mg/kg  (blood  lead:  98.64 ± 9.89 ug/dl).
In this  case,  the  observed  developmental  lag was in the characteristic  decrease  in activity
that normally occurs  in pups at that age (Campbell et al.,  1969; Melberg et al., 1976); thus,
lead-exposed pups were significantly more active than control subjects at PND 18.
     One  question  that arises when ontogenetic effects  are discovered concerns the possible
contribution of  the lead-exposed  dam to her offsprings'  slowed development through, for exam-
ple,  reduced  or  impaired maternal  caregiving  behavior.   A  detailed assessment  of  various
aspects  of  maternal behavior  in  chronically lead-exposed  rat  dams by Zenick et  al.  (1979)f
discussed more fully in Section 12.4.3.1.4, and other studies using cross-fostering techniques
(Crofton et al., 1980; MykkMnen et al., 1980) suggest that the deleterious effects observed in
young  rats  exposed  to  lead via their mothers'  milk are  not ascribable to  alterations  in the
dams' behavior  toward  their  offspring.   Chronically lead-exposed  dams may,  if anything, tend
to respond  adaptively  to  their  developmentally  retarded  pups  by,  for example,  more  quickly
retrieving  them  to the  nest (Davis, 1982)  or  nursing  them for  longer  periods (Barrett and
Livesey, 1983).
                                          12-114

-------
12.4.3.1.2  Locomotor activity.   The spontaneous activity of laboratory animals has been meas-
ured  frequently  and  in  various  ways  as a  behavioral  assay  in  pharmacology and  toxicology
(Reiter and MacPhail,  1982).   Such activity is sometimes described as gross motor activity or
exploratory behavior, and is distinguished from the motor function tests noted in the previous
section by the  lack of a defined eliciting stimulus for the activity.  With reports of hyper-
activity in lead-exposed children (see Section 12.4.2), there has naturally been considerable
interest in the spontaneous activity of laboratory animals as a model  for human neurotoxic ef-
fects of lead  (see  Table 12-3).   As a  previous review  (U.S. Environmental Protection Agency,
1977) of this  material  demonstrated, however,  and  as other reviews (e.g., Jason and Kellogg,
1980; Michaelson, 1980;  Mullem'x, 1980) have since confirmed, the use of activity measures as
an index of the neurotoxic effects of lead has been fraught with difficulties.
     First, there is  no  unitary behavioral  endpoint that can be labeled "activity."  Activity
is, quite  obviously,  a composite of many different motor actions and can comprise diverse be-
havior patterns including (in rodents) ambulation, rearing, sniffing,  grooming, and, depending
on one's operational  definition,  almost anything an animal does.   These various behavior pat-
terns may  vary  independently,  so that  any  gross  measure of activity which fails to differen-
tiate these  components will  be   susceptible  to confounding.  Thus,  different investigators'
definitions of activity are critical to interpreting and comparing these findings.  When these
definitions are  sufficiently  explicit operationally (e.g.,  activity  as  measured by rotations
of an "activity wheel"), they are frequently  not comparable with other operational definitions
of activity (e.g.,  movement in an  open field as detected by photocell interruptions).  More-
over, empirical  comparisons (e.g., Capobianco  and  Hamilton,  1976;  Tapp,  1969) show that dif-
ferent  measures of activity do  not necessarily  correlate with one another quantitatively.
      In addition to these rather  basic  difficulties, activity levels  are influenced greatly by
numerous variables  such  as age,  sex,  estrous cycle,  time of day,  novelty  of environment, and
food  deprivation.   If not  controlled properly, any of  these variables can  confound measure-
ments of  activity  levels.   Also,  nutritional  status  has been a  frequent  confounding variable
in  experiments  examining  the  neurotoxic effects  of  lead  on  activity (see  reviews  by U.S.
Environmental  Protection  Agency,  1977;  Jason and  Kellogg,  1980;   Michaelson,  1980).   In
general,  it appears that rodents  exposed  neonatally  to sufficient concentrations  of lead ex-
perience  undernutrition and  subsequent  retardation in  growth; as  Loch  et al.  (1978) have
shown,  retarded growth  per s_e can induce  increased activity of the same type that has been
attributed to  lead  alone in some  earlier  studies.
      In view  of the various problems  associated with the  use of  activity  measures  as  a behav-
ioral  assay of  the neurotoxic  effects of  lead,  the  discrepant findings summarized  in Table
                                            12-115

-------
                   TABLE 12-3.  EFFECTS OF LEAD ON ACTIVITY IN RATS AND MICE
     Increased
    Decreased
      Age-dependent,
  qualitative, mixed or
        no change
Baraldi et al. (1985)
Czech and Hoi urn (1984)
Driscoll and Stegner (1978)
Goiter and Michael son (1975)
Kostas et al. (1976)
Overmann (1977)
Petit and Alfano (1979)
Sauerhoff and Michael son
  (1973)
Silbergeld and Goldberg
  (1973, 1974a,b)
Weinreich et al.  (1977)
Winneke et al. (1977)
Booze et al. (1983)
Driscoll and Stegner (1976)
Flynn et al. (1979)
Gray and Reiter (1977)
Reiter et al. (1975)
Verlangieri (1979)
Alfano and Petit (1985)
Barrett and Livesey (1982, 1985)
Brown (1975)
Collins et al.  (1984)
Crofton et al.  (1980)
Dolinsky et al. (1981)
Dubas and Hrdina (1978)
Geist and Balko (1980)
Geist and Praed (1982)
Grant et al. (1980)
Gross-Selbeck and
  Gross-Selbeck (1981)
Hastings et al. (1977)
Jason and Kellogg (1981)
Kishi et al. (1983)
Kostas et al.  (1978)
Krehbiel et al. (1976)
Loch et al. (1978)
McCarren and Eccles (1983)
Minsker et al.  (1982)
Mullenix (1980)
Ogilvie and Martin (1982)
Rabe et al. (1985)
Rafales et al.  (1979)
Schlipkb'ter and Winneke
  (1980)
Shimojo et al.  (1983)
Sobotka and Cook (1974)
Sobotka et al.  (1975)
Zimering et al. (1982)
                                          12-116

-------
12-3 should come as  no surprise.   Until the measurement  of  "activity"  can be better standar-
dized,  there appears  to  be little basis for comparing, or utility in further discussing,  the
results of studies  listed in Table 12-3.
12.4.3.1.3  Learning ability.  When  animal  learning studies related to the neurotoxic effects
of lead were reviewed in 1977 (U.S.  Environmental  Protection Agency, 1977), a number of criti-
cisms of  existing  studies  were noted.   A major limitation of early work in this field was  the
lack of adequate information on the exposure  regimen  (dosage  of lead, how precisely adminis-
tered,  timing  of exposure)  and the resulting body burdens of  lead  in experimental subjects
(concentrations of lead  in blood, brain, or other tissue; time course of blood or tissue lead
levels; etc.).   A review of studies appearing  since 1977 reveals a notable improvement in this
regard.   A  number  of more  recent studies  have also attempted to  control  for the confounding
factors of  litter  effects  and undernutrition--variables that were generally not controlled in
earlier studies.
     Unfortunately,  other  criticisms are still valid  today.   The  reliability and validity of
behavioral  assays  remain to be established adequately, although progress is being  made.  The
reliability of  a number of common behavioral  assays  for  neurotoxicity is currently being de-
termined  by  several  independent U.S. laboratories  (Buelke-Sam et  al.,  1985).  The  results of
this program  should  help  standardize  some  behavioral testing  procedures and perhaps create
some reference  methods in behavioral toxicology.   Also,  as well-described studies  are repli-
cated  within  and between  laboratories,  the  reliability of certain experimental paradigms for
demonstrating neurotoxic effects  is  effectively established.
     Some progress is also being made  in  dealing with the issue of the validity of  animal be-
havioral  assays.   As  the  neurological  and  biochemical mechanisms underlying  reliable behav-
ioral  effects  become better  understood,  the basis  for extrapolating  from  one   species to
another  becomes stronger  and more meaningful.  An  awareness  of different species'  phylogene-
tic, evolutionary, and ecological relationships  can  also help elucidate  the  basis  for compar-
ing behavioral  effects in  one  species  with those  observed in another  (Davis,  1982).
     Tables  12-4 and 12-5 summarize exposure  conditions,  testing  conditions,  and  results  of a
number of recent studies  of  animal  learning  (see  U.S. Environmental  Protection  Agency, 1977,
for a summary  of  earlier studies).   The variety  of exposure measures  and  testing paradigms
makes  it impossible to organize  these studies  in a coherent  dose-response  fashion.   Conse-
quently,  the tables  present,  respectively,  rodent  and primate studies arranged alphabetically
by author  and/or  chronologically where appropriate.  One  point  of  obvious interest  is  the
 lowest level  of exposure  at which  behavioral  effects are clearly evident.   Such a determina-
tion is  best  done  on  a  species-by-species basis.  Rats  seem  to be  the experimental  animal
                                           12-117

-------
TABLE 12-4.   RECENT ANIMAL TOXICOLOGY STUDIES OF LEAD'S EFFECTS ON LEARNING IN RODENTS'
                                                                                      a
Reference
Alfano
and Petit
(1985)







Angell
& Weiss
(1982)

rv
i_i
*— »
03
Booze et
al.
(1983)




Bushnell
and Levin
(1983)


Experimental
animal
(species
or strain)
Rat
(L-E)








Rat
(L-E)






Rat
(F-344)





Rat
(S-D)



Lead exposure
cone.
(medium)
0.4 or
4X PbC03
(food)







0.2%
Pb(Ac)2
(water)





3 or 6
ing/ kg
TEL
(15X
ethanol)


10 or
100 ppm
Pb
(water)

period
(route)
PND 1-25
(via dam
and
direct)






PND 3-21
(dam's
milk)
and/or
21-130
(direct)


PND 5,
once
(s.c.)




PND 21-
56
(direct)


Treatment
groups
(n)
C5b (40)
C,0 (50)
Pb, (50)
Pb2 (50)






0-0 (20) ,
0-Pb (20) '
Pb-0 (24) ,
Pb-Pb (24)'




C0C (24)
C15 (23)
Pb, (24)
Pbz (23)



C (6)
Pb, (6)
Pb2 (6)


Litters
per
group
8
5
5
10






5cnl 1 t
I Sp I 1 t
6enl i *•
, Sp M t




random
selection
from 12
litters



?




Tissue lead
(age measured)
See Petit &
Alfano (1979)
for representa-
PbB levels






PbB (130d):
0-0: 2 ug/dl
0-Pb: 66
Pb-0: 9
Pb-Pb: 64



7






Brain- Pbd
(57 d):
C: 0 ug/g
Pb,: 0.05
Pb2: 0.70
Age at
testing
66-
100 d





101-
123 d

58-
130 d






18 d






4, 5,
6, and
7 wk


Testing
paradigm
(task)
Passive
avoidance
(remain in
1 of 2 com-
partments
to avoid
shock);
T-maze
(spontaneous
alternation)
Operant
(multiple
FI-TO-
FR-TO)




Passive
avoidance
(renain
in 1 of 2
compartments
to avoid
shock)
Radial arm
naze (spon-
taneous
alternation)

Non-
behavioral
effects
B.w. of
Cs-Ss >
C0- and
Pb2-Ss






Pb-Pb Ss
sig. lower
b.w. post-
weaning




B.w. of
Pb-Ss
< C-Ss




B.w. of
Pb2-Ss <
C-Ss~


Behavioral
results
Latencies of Pb-Ss
sig. shorter than
C-Ss1; Pb2 latencies
sig. shorter than
C10's. Both Pb
groups performed
sig. less sponta-
neous alternation
than C-Ss.

Groups exposed post-
weaning (0-Pb, Pb-
Pb) had longer
Inter-Response
Tines; group ex-
posed preweaning
(Pb-0) had
shorter IRTs.
Pb,- females showed
sig. poorer reten-
tion of avoidance
than ethanol con-
trols.


Both Pb,- and Pb2-
Ss chose unexplored
amis sig. less often
than C-Ss.


-------
TABLE 12-4.  (continued)
Experimental
aninal
(species
Reference or strain)
Cory- Rat
Slechta (S-D)
&
Thompson
(1979)







Cory- Rat
Slechta (S-D)
et al.
(1981)
i — '
no
i
t— •
Cory- Rat
Slechta (L-E)
et al.
(1983)








Lead exposure
cone.
(Dediua)
1) 50,
2) 300,
or
3) 1000
pp*
Pb(Ac)2
(water)





100 or
300 ppn
Pb(Ac)2
(water)




50, 100
or 500
Pb(Ac)2
(water)








period
(route)
PNO 20-
a) 70 or
b) 150
(direct)








PND
21-?






PND 21-
a) 158 or
b) 315
(direct)








Treatment
groups
(n)
la: .
C (4)e
Pb (5)
Ib:
C (4)e
Pb (6)
2b:
C (3)e
Pb (4)
3b: „
C (4)e
Pb (5)
C (4)
Pbi (5)
Pb2 (5)





C (6)
Pbt (6)
Pb2 (6)
Pb3 (6)








Litters
per
group
random
assign-
Kent









randoH
assign-
ment





randoa
assign-
Kent,
balanced
for b.w.







Tissue lead
(age measured)
PbB (150 d):
C: ~6 jjg/dl
la: -3
Ib: -7
2b: -27
3b: -42






Brain-Pb
(post-test):
C: 14-26 ng/g
Ph,: 40-142
Pb2: 320-1080



PbB (max):
C: <2 ug/dl
Pbi: -40
Pb2: -50
Pb3: -90

Brain-Pb
(336 d):
C: 0.01 (jg/g
Pb,: 0.31
Pb2: 0.57
Pb3: 1.4
Testing Non-
Age at paradigm behavioral
testing (task) effects
55- Operant None
140 d (Fl-30 sec)










55- Operant None
? d (mini BUB
duration
bar-press)




55 d Operant None
(FI-1 m1n)










Behavioral
results
Increased response
rate and inter- S
variability in both
Pbi . and Pb2
groups; decreased
response rate in Pb3
group; effects in
Pb! reversed after
exposure terminated.



Pb groups impaired:
decreased response
durations; increased
response latencies;
failure to improve
performance by
external stimulus
control .
Higher response
rates in Pb-Ss;
number of sessions
to reach max.. rate
a direct function
of Pb expos. Early
vs. late teraina-
nation of exposure
period produced no
difference in re-
sponse rates.
sponse rates.

-------
TABLE 12-4.  (continued)
Experimental
aniaal
(species
Reference or strain)
Cory- Rat
Slechta (L-E)
et al.
(1985)

Dietz Rat
et al. Expt. l(L-E)
(1978)


Expt. 2(CD)


i— *
no
i
i— •
I\5
O
Flynn Rat
et al. (L-E)
(1979) Expt. 1



Expt. 2








Expt. 3






Lead exposure Treatment
cone.
(BediUM)
25 pp.
Pb (Ac)2
(water)


200
•gAg
Pb(Ac)2
(gavage)

250 ppa
Pb
(water)




0.5X
Pb(Ac)2
(water)



0.2X
Pb(Ac)2
(water).
225 •gAg
Pb
(gavage),
0.25X
Pb(Ac)2
(water)
saae
as above
except 90
•gAg Pb
(gavage)


period
(route)
PND 21-
tenaina-
nation
(direct)

PND
3-30
(direct)


Preconcep-
tion to
termination
(via da*
until weaning
then direct)

Preconception
- PND 22
(via daa)



Preconception
- birth
(via daa).
birth -
weaning
(direct).
weani ng
- termination
(direct)
saae as
above except
stopped at
PHD 33



groups
(n)
C (12)
Pb (12)



C (6) ,
Pb (7)j



C (4)e
Pb (4)


1


C (8)
Pb (10)




C (12)
Pb (12)







C (10) ,
Pb (10)J





Litters
per Tissue lead Age at
group (age Measured) testing
randon PbB (99, 143, 50 d
assign- 186 d):
Bent, C: <1 ug/dl
balanced Pb: 15-20
for weight
2 snlit ? 3 "°
2. split or
21 mo


? ? 8 no






8 Brain-Pb ?
10 (3 d):
C: -0
Pb: 0. 174 ug/g
(30-34 d):
no sig. diffs.
6 (75-76 d): 49-
6 C: 0.13 ug/g 58 d
Pb: 1.85






. see above 58-
* 60 d





Testing Non-
paradig* behavioral
(task) effects
Operant
(FI-1 win)



Operant
(aininuB
20-sec
between
bar-presses)







Radial
am aaze
(spontaneous
alternation)


Passive
avoidance
(reaain
in 1 of 2
coBpartaents
to avoid
shock)


Shuttle-box
signalled
avoidance
(BOVC fro* one
co*part»ent to
other to avoid
elect, shock)
None




None




Pb-Ss b.w.
lower 1 wk.
prior to
test; C-Ss
reduced to
same wt.
at test.
Brain wts.
of Pb-Ss
< C-Ss;
no other
differences.

None








Non*






Behavioral
results
Sig. higher response
rate and shorter
IRTs by Pb-Ss during
first 40 sessions.

Short IRTs (S4 sec)
more prevalent in
Pb-Ss than in
C-Ss", but did not
result in different
reward rates; Pb-Ss
showed higher varia-
bility in response
rate under d-aaphet-
aBine treataent.


No sig. difference
between Pb-Ss
and C-Ss.



No sig. difference
in trials to crite-
rion, but Pb-Ss Bade
sig. fewer partial
excursions froa
"safe" coapartaent.



No sig. difference
between Pb-Ss
and C-Ss.





-------
TABLE 12-4.  (continued)
Reference
Geist
& Mattes
(1979)


Geist
et al.
(1985)

t— >
ro
i
i — >
ro
i— •
Gross-
Selbeck
& Gross-
Selbeck
(1981)



Hastings
et al.
(1977)






Experimental
ani*al
(species
or strain)
Rat
(S-0)



Rat
(S-D)






Rat F,
00



F2


Rat
(L-E)







Lead exposure Treatment
cone.
(medium)
25 or
50 pp.
Pb(Ac)2
(water)


25 or
SO pp.
Pb(Ac)2
(water)




i a/kg
Pb(Ac)2
(food)


II


109 or
545 ppm
Pb(Ac)2
(water)





period
(route)
MM) 23-
termi nation
(direct)


PND 21-
65
(direct)





Postweaning
- termination
(direct)


Preconception
- weaning
(via dam)
PNO 0-
21
(dan's
•ilk)





groups
(n)
C (7)
Pbt (7)
Pb2 (7)


C (6)
Pbj (6)
Pb2 (6)





C (6)
Pb (6)



C (6)
Pb (6)

C (12)
Pbj (12)
Pb2 (12)






Litters
per Tissue lead
group (age measured)
? ?




? ?







? PbB
(-180 d):
C: 6.2 ug/dl
Pb: 22.7

? (-110 d):
C: 3.7
Pb: 4.6
randon PbB
selection (20 d):
fron 9 C: 11 ug/dl
litters Pbj: 29
Pb2: 42
(60 d):
C: 4
Pbt: 5
Pba: 9
Testing Non-
Age at paradign behavioral
testing (task) effects
58-? d Hebb- None
Williams
maze
(find way
to goal
box)
61 d T-«aze None
( spontaneous
alternation);
143 d Hebb- Will Jains
naze (find
way to goal
box)

Adult Operant None
(DRH)



3-4 BO


-90- Operant None
186 d (successive
brightness
discrin. )





Behavioral
results
Pbi- and Pb2-Ss
•ade sig. More
errors than C-Ss;
Pb2-Ss slower
thaiTC-Ss to
traverse maze.
Rate of spontaneous
alternation sig.
reduced in Pb-Ss.
No sig. differences
in H-W naze except
except for shorter
latency of Pb-Ss to
leave start box.
Both F! and F2
(especially F2)
Pb-Ss had greater
X rewarded responses
than C-Ss, i.e. ,
Pb-Ss bar-pressed
at higher rate
than C-Ss.
No sig. differences
between Pb-Ss
and C-5s in"
learning original
or reversed
di scrim, task.




-------
TABLE 12-4.  (continued)
Reference
Hastings
et al.
(1979)







Hastings
et al.
(1984)

i— •
PO
i — »
rO
ro


Kishi
et al.
(1983)







Kowalski
et al.
(1982)


Experimental
animal
(species
or strain)
Rat
(L-E)








Rat
(L-E)








Rat
(W)








House
(W)



Lead exposure
cone.
(medium)
0.02
or
0.2X
Pb(Ac)2
(water)





0.10X
or 0.20X
Pb(Ac)2
(water)






45, 90,
or 180
M9/9
b.w.
(water)





2 pp. Pb
(water)



period
(route)
?ND 0-21

(dan's
•ilk)






PHD 0 to
a) 30
(dai's
•ilk)
or
b) term-
nation
(direct)


PHD 3-21
(gavage)








Adult
(direct)



Treatment
groups
(n)
C (23)
Pbt (11)
Pb2 (13)







C (22)
Pbt (25)
Pb2_ (22)
Pb2? (23)
D





C (10)
Pbi (10)
Pt>2 (10)
Pb3 (9)






C (16)
Pb (16)



Litters
per
group
random
selection
from 15
litters






random
selection
fro* 49
litters






random
selection








1




Tissue lead
(age Measured)
PbB (20 d):
C: 11 ug/dl
Pbt: 29
Pb2: 65

Brain- Pb
(20 d):
C: 12.5 ug%
Pb1= 29
Pb2: 65
PbB
(20 d):
C: 3 ug/dl
Pbt: 30
Pb2 : 57
Pb2': 40
(90Dd):
C: 5
Pb^ 31
Pb2 : 9
Pb2a: 42
PbB (22d):
C: 10 ug/dl
Pbt: 59
Pb2: 152
Pb3: 186





?




Age at
testing
120 d


270 d


330 d



-90 d









75-270 d









Adult
(13 d
after
start of
exposure)
Testing Hon-
paradign behavioral
(task) effects
1) Operant None
(simult. vis.
di scrim. )
2) T-maze
(success, vis.
discria.)
3) Operant
(go/no-go task)


Operant None
(1) spatial
discr. with
successive
reversal s ;
2) siault.
visual discr.)



Operant B.w. of Pb3-
(1) CRF Ss < C-Ss
2) FR 20
3) EXT
4) DRL 20- sec
5) EXT)




Water T-*aze None
(spatial
discria. )


Behavioral
results
Pb2-Ss sig. slower
to reach criterion
than C-Ss on
simultaneous visual
discrimination task;
no sig. differences
on successive and
go/no-go discria.
tasks.

No sig. differences
in performance except
for sig. pos. corre-
lation between day-20
PbB levels and number
of non- rewarded re-
sponses between trials.



Sig. greater varia-
bility in CRF re-
sponding by Pt>! and
Pb3-Ss. No sig.
differences in
mean response
rates except Pbt-
Ss better than C-
5s at end of DRL
training.
Pb-Ss made more
errors than C-Ss;
food deprivation
exacerbated effect.


-------
TABLE 12-4.  (continued)
Reference
Lanthorn &
Isaacson
(1978)





He Lean
et al.
(1982)


£Hilar
i et al.
£ (1981i>)
CO

Nation
et al.
(1982)

Experiwntal
aninal
(species
or strain)
Rat
(L-E)






House
(Swiss)



Rat
(L-E)



Rat
(S-D)


Lead exposure
cone.
(MediuM)
0.27X Pb
(water)






20 or
2000 ppM
Pb
(water)

25. 100,
or 200
•g/kg b.w.
Pb
(gavage)
10 Mg/kg
b.w. Pb
(food)

period
(route)
Adult
(direct)






Adult
(direct)



PMO 4-31
(direct)



PMD 100-
terai na-
tion
(direct)
Treatment
groups
(n)
C (4)
Pb (6)






C (16)
Pb, (16)
Pbj (16)


C (10)
Pb» (5)
Pb2 (4)
Pb3 (6)

C (8)
Pb (8)


Litters
per Tissue lead
group (age Measured)
7 7







? ?




3 PbB (32 d):
4 C: 5 ug/dl
4 Pb,: 26
4 Pb2: 63
Pb3: 123
7 7



Age at
testing
Adult







Adult
(10 d
after
start of
exposure)
50 d




156 d



Testing
paradign
(task)
T-Maze
(1) spontane-
ous alterna-
tion
2) light
discriM.
3) spatial
discriM.)
Water T-naze
(spatial
discriM.)


Operant
(spatial
alternation
levers)

Operant
(conditioned
suppression
of respond-
Non-
behavioral
effects
C-Ss
pan— fed
to control
for loss
of b.w.



None




Sig. slower
growth rate
in Pb3-Ss


None



ing on multiple


OverMann
(1977)













Rat
(L-E)













10, 30,
or 90
Pb(Ac)2
(gavage)











PHO 3-21
(direct)













C
Pbt 12-
Pb2 25
Pb3 ea.











? PbB (21 d):
C: 15 ug/dl
Pbt: 33.2
Pb2: 173.5
Pb3: 226.1










26-29 d




67-89 d




79-101 d
83-105 d
95-117 d
VI schedule)

Avers ive
conditioning
(1) active
2) passive)

Operant
(inhibit
response)
E-maze
di scrim. :
(1) spatial
2) tactile
3) visual)


None












Behavioral
results
Pb-Ss had sig.
lower rate of
spontaneous alterna-
tion; Pb-Ss sig.
slower than C-Ss
only on 1st spatial
discrin. task.

Pb-Ss showed no
i«prove»ent in
performance coir-
pared to C-Ss.

No sig. differences
between C-Ss
and Pb-Ss.


Presentation of tone
associated with
electrical shock
disrupted steady-
state responding
More in PB-Ss than
in C-Ss.
Pb3-Ss sig. slower
in acquisition and
extinction of active
avoidance response;
no sig. diffs. for
passive avoidance.
All Pb groups failed
to inhibit responses
Pb2 3-Ss sig. worse
than C-Ss only on
tactile discrim.



-------
TABLE 12- C-Ss;
gross
toxicity
in Pb2-Ss;
lower brain
wts. in
Pbt-Ss

B.w. of
Pb-Ss <
C-Ss at
birth
(includes
pair- fed
C2-Ss)
Behavioral
results
Pb-Pb group
had sig. fewer
rewarded responses
and took sig. longer
to complete FR 20
requirement.






Pb-Ss showed
slower acquisition
(in terms of speed
and rate, but not
errors); by 3rd
session, no sig.
diffs. except that
Pb-Ss made sig.
fewer errors than
C-Ss.
No sig. diff.
between Pb- and O
Ss in naze learning;
Tsol at i on- reared
Pb-Ss less success-
ful than C.-Ss
on passive-avoidance
task; enrichment-
reared Pbj-Ss = C-Ss
but Pb2 -Ss sig.
worse on passive
avoidance.
No sig. diffs. in
acquisition or
reversal errors.



-------
TABLE 12-4.  (continued)
Experimental
animal
(species
Reference or strain)
Rosen Rat
et al. (L-E)
(1985)








,_,
PO
t
! — '
in
Schlipkbter Rat
& Winneke (?)
(1980) Expt. 1



Expt. 2





Cwn+ ^
txpt . 3



Expt. 4




Lead exposure Treatment Litters
cone.
(nediun)
10 ng/kg
b.w.
Pb(Ac)2












25pp.
Pb
(food)



75 ppm
Pb
(food)




	 Sane as



25 or
75 ppm
Pb
(food)


period groups per
(route) (n) group
PND 1-20. Ci (16) •> . ,.
daily Pb, (15) ' ' p
(i.p.) C2 (8) , - ,.
Pb2 (8) ' 2> Sp1lt











Preconception C (10) ?
- PND 120 Pbt (18)
(via dan)
and direct)


a) Prenatal- C (10) ?
7 mo (via Pb2 (10)
dam and Pb2b (10)
di rect
b) Prenatal -
weaning
(via dan)
Expt. 2 	 C (14) ?
Pb3a (14)



Prenatal C (10) ?
- 7 mo Pb« (10)
(via dam Pb4b (10)
and direct)


Tissue lead
(age measured)
PbB (21 d):
C,: 3 M9/dl
Pb,: 158
(180 d):
C2: 5
Pb2: 8









PbB:
all C: <5 ng/dl
Pbj (21 d):
39.5
(4- mo):
12.0
Pb2 :
(21ad) 29.2
(7 mo) 27.0
Pb2.:
(21Dd) 29.2
(7 mo) 5.2

Pb3 :
(21ad) 29.9
(7 mo) 30.8
(21bd) 29.9
(7 mo) 1.8
(120 d)
Pbt -. 17.8
Pb4*: 28.6



Testing Non-
Age at paradigm behavioral
testing (task) effects
1) 30- Radial-arm B.w. of
50 d maze (find Pb-Ss <
and/or food in each C-Ss at
2) 150 d of 8 arms); 25 d. but
passive not sig.
avoidance after 50 d
(remain in
1 of 2 com-
partments to
avoid shock)





7 mo Lashley ?
jumping
stand
(size
di scrim. )

II II f





II II •>




" Water ?
maze
(spatial
di scrim. )


Behavioral
results
No sig. differences
on radial arm naze
for either Pbj
(young) or Pb2
(adult) Ss. Sig.
longer latency on
passive avoidance
for Pbj-Ss, but not
when retested as
adults. Pb2-Ss
tested first time
at 150 d had sig.
shorter latencies
(i.e. , performed
worse than C-Ss).
Sig. increase in
error repetition
by Pb,-Ss.



Non-sig. (p <0.10)
increase in error
repetition by Pb2-
Ss.



No sig. differences
between Pb3-Ss
and C-Ss.


35% of Pb4-Ss failed
to reach criterion
(vs. 10X C-Ss); 35%
also failed retest
after 1 wk (vs. OX
C-Ss).

-------
TABLE 12-4.  (continued)
Reference
Taylor
et al.
(1982)





Winneke
et al.
(1977)

t— »
IV>
t— *
IS>
cpl

Winneke
et al.
(1982D)








Zenick
et al.
(1978)


Experiment!
animal
(species
or strain!
Rat
(CD)






Rat
(W)







Rat
(W)
Expt. 1




Expt. 2



Rat
(CD)



il
Lead exposure Treatment
cone.
) (medium)
200 or
400 »g/l
Pb(Ac)2
(water)




1.389
Pb(Ac)2
per kg
diet
(food)




80, 250
or 750
pp* Pb
(food)



-Continuation



1000
•g/kg
Pb(Ac)2
(water)

period groups
(route) (n)
Preconception
- weaning
(via dam)





Preconception
- testing
(via dan
and
direct)




Preconception
- testing
(via dam
and
direct)


of Expt. 1-



Preconception
- weaning
(via dan)


C (12)
Pbj (16)
Cz (4)
Pb2 (4)




C (20)
Pb (20)







C (16)
Pb, (16)
Pb2 (16)
Pbs (16)



C (10)
Pb2 (10)
Pb3 (10)

C (10)
Pb (10)



Litters
per Tissue lead
group (age measured)
69 PbB (21 d):
89 C: 3.7 ug/dl
29 Pbt: 38.2
29 Pb2: 49.9




? PbB
(random (-16 d):
selection C: 1.7 ug/dl
fron Pb: 26.6
110 male (-190 d)
pups) Pb: 28.5



random ?
selection
frwi 5-6
litters
per condi-
tion

(females ?
dropped;
no Pt>! group
for Expt. 2)
5 ?
5



Testing Non-
Age at paradigm behavioral
testing (task) effects
11 d Runway
(traverse
alley to
reach dan
and dry
suckle)


100- Lashley
200 d jumping
stand
(visual
di scrim.
of stimulus:
Dorientation
2)size)

70- Shuttle-box
100 d signalled
avoidance
(move from
one compart-
ment to avoid
elect, shock)
190- Lashley
250 d jumping stand
(size discrim.

30- Water T-maze
40 d (1) black-white
discrim.
55- 2) shape
63 d discrim. )
None







B.w. of
Pb-Ss > C-Ss;
however, size
of Pb-Ss
1 i tters
< C-S
litters.


ALA-D at
SO d:
C: 7.05 U/l
Pb^ 4.26
Pb2: 1.92
Pb3: 1.18



)

B.w. of
Pb-Ss <
C-Ss from
birth to
50 d.
Behavioral
results
No sig. differences
in acquisition of
response, but
both Pb groups
sig. slower to
extinguish when
response no longer
rewarded.
Pb-Ss sig. slower
to learn size
discrimination;
no difference
between Pb and C
groups on orienta-
tion discrim. (a
relatively easy
task).
Expt. 1 Pb-Ss sig.
faster than C-Ss to
learn avoidance
response.



Expt. 2 Pb-Ss
sig. slower than
C-Ss to learn
size discrim.
On both discrim.
tasks, Pb-Ss
made sig. more
errors with sig.
shorter response.

-------
                                                                TABLE 12-4.   (continued)



Reference
Zenick
et al.
(1979)





Experimental
animal Lead exposure Treatment Litters
(species cone. period groups per
or strain) (medium) (route) (n) group
Rat 750 Preconception 0-0 (?) 5
(CD) ag/kg to Pb-0 (?) 5
Pb(Ac)2 a) weaning Pb-Pb (?) 5
(water) (via dam)
or
b) termination
(via dam
and direct)


Tissue lead
(age measured)
?








Testing

Non-
Age at paradigm behavioral Behavioral
testing (task)
42-? d Operant
(FI-1 min)






effects results
B.w. of Pb-Pb group had sig.
Pb-Ss fewer rewarded
< 0~Ss responses across
from birth sessions than Pb-0
to weaning. or 0-0 groups.



a Abbreviations and symbols:
! — ' -
IX. •
^ ALA-D
rx> b.w.
^ C.
CD
CRF
ORH
DRL
IM
Fj

F-344
FI
FR
i.p.
IRT
r.,-Sc rxntt
information not given in report
delta aninolevulinic acid dehydrase
body weight
control group
substrain of Sprague-Dawley
continuous reinforcement for each response
differential reinforcement of high response rates
differential reinforcement of low response rates
extinction
1st filial generation
2nd filial generation
Fischer-344
fixed interval
fixed ratio
intraperitoneal injection
inter response tine
* fro« litters of 5 mine parh- P.~-^c frnm 1-itforc nf in- hnth
L-E
Pb
Long-Evans

lead-exposed group (subscript indicates exposure level or
other experimental condition)
Pb(Ac)2
PbB
PbC03
PND
S
s.c.
S-D
TEL
TO
U/l
VI
W
WGTA
Ph nrnnnc frnm lit
lead acetate
blood lead
lead carbonate
post-natal day
subject
subcutaneous injection
Sprague Daw ley
tri ethyl lead
time out









unole ALA/min x liter erythrocytes
variable interval
Wistar
Wisconsin general testing
tors nf R parh


apparatus

cC0-Ss sham injected; C15-Ss injected with 15% ethanol.
 For Ss on zinc-replete diet;  Ss on zinc-deficient  diet  had higher Pb concentrations.
Height-matched controls.
 Pair-fed and -watered controls.
^Inferred from information in report.

-------
TABLE 12-5.   RECENT ANIMAL TOXICOLOGY STUDIES OF LEAD'S EFFECTS ON LEARNING IN PRIMATES
Lead exposure
Reference Species
Bushnell Macaca
& Bowman mulatta
(1979a)
Expt. 1




Expt. 2
Test 1

) — '
ro
i
^-j>
ISJ
OO

T_ -* o
I est £.






Test 3






cone.
(medium)
-0.53 or
1.15
mg/kg
Pb C«ilk)
adjusted
to main-
tain tar-
get PbBs
-0.25 or
1.06
rag/kg
Pb (ni Ik)
adjusted
to main-
tain tar-
get PbBs











after





period
(route)
Birth -
1 yr
(direct)





Birth -
1 yr
(direct)














Continual! 01
Treatment
groups
(n)
C (4)
Pbt (3)
Pb2 (3)





C (4)
Pbj (4)
Pb2 (4)







'Continuation of Expt.







n of Expt. 2 	
exposure terminated at 12 no










Tissue lead
(age measured)
PbB (1st yr)b:
C: ~5 ug/dl
Pbj: 37
Pb2: 58




PbB (1st yr)b:
C: -4 (jg/dl
Pb,: 32
Pb2: 65






	






PbB (16 mo):
C: ~5 ug/dl
Pb^ 19
Pb2: 46



Testing Non-
Age at paradigm behavioral
testing (task) effects
5- WGTA (form None
10 mo discrim.
reversal
learning)




1.5- 2-choice None
4.5 mo maze
(discr.
reversal
learning)
non- food
reward


5Uf*TA UnnA
WG1 A None
12 mo (series
of 4
reversal
discr.
problems)


15 mo WGTA None
(discr.
reversal
learning,
more
difficult
cues)
Behavioral
results
Both Pb groups
retarded in rever-
sal learning;
Pbz-Ss especially
impaired on 1st
reversal following
overtraining.

Pb2-Ss sig.
retarded on 1st
reversal (confirms
Expt. 1 using dif-
ferent task and
reward to control
for possible con-
founding by motiva-
tional or motor
factors).
Both Pb groups
retarded in
reversal learning;
Pb2-Ss
impaired on 1st
reversals regard-
less of prior over-
training.
Pb2-Ss retarded
on 1st reversal.






-------
TABLE 12-5.  (continued)
Reference
Bushnel 1
& Bowman
(1979b)




Mele et
al. (1984)



Levin and
Bowman
Q983)
£ Expt.
ro
§ Expt.





Laughlin
et al.
(1983)







Species
Macaca
mulatta





Macaca
mulatta



Macaca
mulatta

1 (Continuation

2 (Continuation





Macaca
aulatta








Lead exposure
cone. period
(medium) (route)
--Continuation of Bushnel 1






— Continuation of Bushnell




0.29 or Birth -
0. 88 ng/kg 1 yr
Pb (milk) (direct) .
of Expt. 2 of Bushnell &

of Expt. 4 of Bushnell &
3 or 6 Preconception
mg/kg - Birth
Pb(Ac)2 (via mother)
(water)

-10 ng/kg Weeks 5-6
and/or and/or
-0.5 mg/kg birth-
b.w. Pb 1 yr
(•ilk) (direct)





Treatment
groups
(n)
& Bowman (1979a)—






4 Bowman (1979a)—
C (4)
Pb, (3)
Pb2 (3)

C (3)
Pb, (4)
Pb2 (3)
Bowman, 1979a)

Bowman, 1979c)
C (5)
Pbi (3)
Pb2 (4)


C (4)
Phx (4)
Pb2 (4)
Pb3 (4)






Tissue lead
(age measured)
PbB (56 mo):
C: 4 ug/dl
Pbj: 5
Pb2: 6



PbB (37 mo):
C: 3 ug/dl
Pbj: 5
Pb2: 11

PbB (1st yr):
C: ~5 jjg/d!
Pbt: 40
Pbz: 85


Pbfi (birth):
C: 5 ug/dl
Pb,: 30
Pb2: 55

PbB (12 mo):
C: 3.4 ug/dl
Age at
testing
49-
55 mo





33 mo




4-5
yr




4-5
yr



a: 12 mo
b: 16 no
Pb,: 8.6 (pulse only)
Pb2 53.4 (chronic
Pb3 55.0 (chronic
(16 mo):
C: 4
Pb,: 7.8
Pb2: 29.5
Pb3: 30.2
only)
& pulse)





Testing Non-
paradigm behavioral
(task) effects
WGTA None
(spatial
discr.
reversal
learning)


Operant None
(FI-1 min)



WGTA- None
Hamilton
search task
(find food
under 6 boxes)

Same None
(find food
under 8
boxes)

WGTA None
(discr.
reversal
learning:
a: without
overtrng;
b: with
overtrng.)


Behavioral
results
Both Pb groups
retarded in rever-
sal learning;
3 Pb2-Ss failed to
retain motor pattern
for operating MGTA
from 2 yr earlier.
Rate of acceleration
in FI pattern of
responding sig. re-
duced in Pbj + Pb2
Ss.
Pb-Ss sig. slower
to reach criterion
(examine 6 boxes
without repeats).


No sig. differences
in Pb- and C-Ss; all
Ss had equal diffi-
culty with criterion
of 8.
No differences between
Pb- and C-Ss at 12 mo;
Pbj and Pb3 (pulse
exposed) slower to
reach criterion on
reversal at 16 no;
no sig. difference
between Pb2- and
C-Ss.


-------
                                                                    TABLE 12-5.  (continued)
CO
o
Lead exposure
Reference
Rice
& Willes
(1979)
et al.
(1979)
Rice (1984)
Rice (198Sa)
cone.
Species (Bediua)
Macaca 500
fascicu- ug/kg
TarTs b.w. Pb
(•ilk)
	 	 Continuation of
Macaca 500 ug/kg
fascicu- b.w. Pb
laris (Milk)
Macaca 50 or
fascicu- 100 ug/kg
laris Pb («ilfc)

period
(route)
Birth -
life
(direct)
Rice & Willes
Birth -
life
(direct)
Birth -
life
(direct)
Treatment
groups
(n)
C (4)
Pb (4)
(1979) 	
C(4)
Pb (4)
C (7)
Pbi (8)
Pb2 (5)
Tissue lead Age at
(age measured) testing
PbB 421-
(200 d): 714 d
C: <5 ug/dl
Pb: 35-70
(400 d):
Pb: 20-50
PbB (400+ d): 2.5-
20-30 pg/dl 3 yr
PbB (peak): 3-
C: <5 ug/dl 3.5 yr
Pb: 55.3
(steady state):
Pb: 32.8
PbB (peak): 3-4
C: 3.5 ug/dl yr
Pbi; 15.4
Pb2: 25.4
(steady state):
C: 2.9
Pb^ 10.9
Pb2: 13.1
Testing Non-
paradign behavioral
(task) effects
WGTA None
(form
discrioi.
reversal)
Operant None
(multiple
FI-TO)
Operant None
(delayed
•atching to
sanple for:
1) color
2) position)
Operant None
(1) for* (incl. b.w.
discr. and blood
reversal; chem'stry)
2) color
discr. reversal;
3) fom
discr. reversal,
color irrelevant)
Behavioral
results
Pb-Ss slower
to learn successive
reversals.
Pb-Ss responded
at higher rates,
had shorter IRTs,
and tended to
respond store during
tine-out
(unrewarded).
Pb-Ss performed both
lasts sig. worse
than C-Ss, although
no difference in ac-
quisition or at 0
delay. Pb-Ss Bade
perseveratTve errors
on color Hatching
task.
Pbx-Ss sig. worse
than C-Ss on last 4
of 15 reversals for
all 3 tasks, i.e. ,
did not improve as
•uch as C-Ss; Pb2-Ss
sig. worse than C-5s
on all reversals.

-------
                                                                 TABLE 12-5.   (continued)

Reference
Rice (19856)
Gilbert
(1985)

Species
Nacaca
fa^cicu-
laris
fascicu-
laris
Lead exi
cone.
(medium)
2000
ug/kg
b.w. Pb
(•ilk)

oosure
period
(route)
Birth -
life
(direct)

Treatment
groups
(n)
C (6)
Pb (6)


Tissue lead
(age Measured)
PbB (peak):
C: 3.1 M9/dl
Pb: 115.0
(steady state):
C: 3.5
Pb: 33.0


Age at
testing
a: 0-9
•°;
b: 3-4
yr

Testing
paradigm
(task)
Operant
(a: FI
2 Bin
or FR 10-40;
b: Milt
FI-FR)
(ORL)
Non-
behavioral
effects
None


Behavioral
results
At 0-9 »o, Pb-Ss
paused sig. longer;
at 3-4 yr, Pb-Ss had
sig. shorter IRTs,
higher response
rate and greater
variability of re-
sponse rate.
learning to respond
at low rate; also
 Abbreviations:

b.w.          body weight
C             control  group
DRL           differential reinforcement  of  low  response rates
FI            fixed interval
FR            fixed ratio
IRT           inter response tinte
Pb            lead-exposed group (subscript  indicates exposure level or other experimental  condition)
Pb(Ac)2       lead  acetate
PbB           blood lead
S             subject
WGTA         Wisconsin general testing apparatus

Corrected annual  averages obtained from Bushel 1 (1978).
                                                                                                                                      sig.  greater
                                                                                                                                      session-to-session
re
i— »
co
i— »
Winneke Hacaca
et al. mulatta
(1S83);
Lilienthal
et al.
(1983)
Zook et al . Hacaca
(1980) iuTitta







350 or
600 ppm
Pb(Ac)2
(food)


1) 300
•3/kfl
or
2) 100
•g/kg Pb
(paint)



Preconception
-5 MO post-
natal (via
•other and
direct)

1) 10-23 wk
fro* age
6-8 *o or
2) 43-113 d
from age
5-12 d
(direct)


C (6)
Pb, (5)
Pb2 (6)



G! (3)c
Pbt (41
C2 (2)C
Pb2 (4)





PbB (post-test): ?
C: 9.6 ug/dl
Pb,: 51.7
Pb2: 71.4


PbB (tern.): 1) 15-16 K>
C: 12 M9/dl 2) 6 mo
Pbj: 470
Pb2: 96





WGTA ?
(series of
36 di scrim.
problems)


WGTA Various
(series of clinical
10 stimulus signs
discria.
problems)


variability in per-
formance during
terminal sessions.
Sig. dose-related
deficits in learning
set formation in
both Pb groups.


No sig. difference
in Mean number of
errors.




 age-
      atched controls.

-------
selected for  the great  majority  of the  behavioral  studies, despite  concerns that  have  re-
peatedly been  expressed concerning the appropriateness of  this  species as a  subject  for  be-
havioral investigation (e.g., Lockard,  1968, 1971; Zeigler,  1973).
     A  number  of studies have reported alterations in learning  task performances  by rats with
blood  lead  levels below 30  ug/dl.  The  lowest exposure level to be  significantly  associated
with a  behavioral  effect was reported by Bushnell and Levin (1983), who exposed rats from  PND
21 (postweaning) to a drinking water solution of 10 ppm lead for 35  days.   Although  blood  lead
concentrations were not  measured,  brain  lead levels at PND  57  (the day following termination
of lead  exposure)  averaged  0.05 pg/g.   By comparison with other  studies  in which lead levels
in blood as well as brain were determined  at  a similar age  (Collins  et al.,  1984;  Grant  et
al. ,  1980;  Bull  et al., 1979),  it would appear  that  the   animals  in question  probably  had
maximum blood  lead levels under 20 ug/dl.
     The behavior  assessed  by Bushnell and Levin  (1983)--spontaneous  alternation in a radial
arm maze—could  be  described as a form of  natural  or unrewarded learning, since  there was no
experimenter-imposed  contingency  of reinforcement  for  alternating  between different  arms of
the maze before  reentering  a previously selected  arm.  Other testing  paradigms have also  re-
vealed  behavioral  alterations  in  subjects exposed to quite  low  levels of  lead.  For example,
Cory-Siechta  et al.   (1985)  reported   significant  effects  in rats   exposed postweaning to  a
25-ppm  lead  acetate  solution for  their  drinking water.    Exposure continued  throughout  the
course  of  the experiment,  with blood lead  levels stabilizing  at  15-20 ug/dl  by PND  99  (the
first  point of measurement), by which time  the behavioral  effects  were already  evident.   In
this case,  the outcome was a significantly higher response rate  in the lead-exposed  animals on
a fixed-interval  operant schedule  of  food reinforcement.   Consistent with this  finding,  the
interval between  bar-press  responses  was  also significantly shorter in the lead-exposed rats.
Cory-Slechta and her colleagues obtained similar results at  higher exposure levels in a series
of earlier  studies (Cory-Slechta  and  Thompson, 1979; Cory-Slechta et al., 1981, 1983),  even
when the operant schedule or contingency for reinforcement was rather different.  For example,
in the experiment by Cory-Slechta  et al.  (1981), a bar-press of  a certain minimum  duration  was
required before  the rats could be rewarded.  Subjects  exposed  to  100 or 300 ppm  lead acetate
solutions for drinking water were  impaired in their ability  to meet  this response  requirement.
     A  tendency  to  respond  more rapidly (higher  response rate,  shorter inter-response times,
shorter  response  latencies)  or to respond even when inappropriate (when no reward is provided
for responses  or when  reward is   specifically  withheld for  responding) has  been reported in
quite  a few other  studies  of  lead-exposed  rats  (Alfano and Petit, 1985; Angell  and Weiss,
1982;   Cory-Slechta  and  Thompson,  1979;  Cory-Slechta  etal.,  1983;  Oietz  etal,,  1978;
Gross-Selbeck   and Gross  Selbeck,  1981; Hastings et al., 1984; Nation  et al. , 1982; Overmann,

                                          12-132

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1977; Padich and Zenick, 1977; Rosen et al., 1985; Taylor et al., 1982; Winneke et al., 1982b;
Zem'ck et al.,  1978).   In many of  these  investigations the lead exposure  levels  were rather
low, resulting in blood lead concentrations under 30 ug/dl at the time of assessment (although
peak levels may have been considerably higher).
     Additional forms of impairment have been reported in studies using other behavioral test-
ing  paradigms.   Winneke  and his  associates  (Winneke  etal.,  1977, 1982b;  Schlipkoter  and
Winneke,  1980) employed an apparatus requiring the subjects to discriminate between stimuli of
different sizes  and found that lead-exposed  rats were  slower to learn  the discrimination or
tended to  repeat errors more than  control  subjects.   In these  studies,  exposure  occurred jn
utero as well  as via the dam's milk  and  directly through the subjects'  drinking  water post-
weaning.   Blood  lead levels  around PND 16 were  less than  30 |jg/dl  in  the  study of Winneke
et al. (1977).   A  number of other reports have also noted impaired discrimination acquisition
or performance  in  various testing paradigms with rats  (Booze et al., 1983; Geist and Mattes,
1979;  Hastings  etal.,  1979;  Kowalski  etal.,  1982;  McLean  etal.,  1982;  Overmann, 1977;
Penzien et al., 1982; Zenick et al., 1978).
     Nonhuman primates have been studied in several studies of the effects  of  lead on learning
ability (Table 12-5).   For  the  most part, these  studies  have exposed monkeys  directly to  lead
from  birth  and  then analyzed  the subjects'  ability to discriminate  stimuli differentially
associated  with  rewards.  A  number of these  studies were  conducted by  Bowman  and his col-
leagues  (Bushnell  and  Bowman,  1979a,b;  Levin  and Bowman,  1983;  Laughlin et al., 1983; Mele
et al., 1984).  Using a  variety of tasks and different groups of subjects  (as  well as the  same
subjects followed  for several months or years after  exposure terminated),  these investigators
have  consistently  found evidence  of impaired learning ability in monkeys,  even after the  sub-
jects' blood  lead  levels  had dropped to control values, i.e., ~5 |jg/dl (see Section 12.4.3.1.5
for  further discussion  on  the  persistence  of neonatal  exposure effects).   One  type of  test
that  has been frequently used to detect lead-induced  impairment  in primates is the discrimina-
tion  reversal task.   Discrimination reversal tasks require the subject to correctly respond to
one  of  two  stimuli associated with reward  and then,  once that task has  been  mastered,  to  make
the  reverse  discrimination,  i.e.,  respond only to the cue formerly  unpaired  with  reward.
Greater difficulty in learning  such reversals by  lead-exposed monkeys has been shown  repeated-
ly by Bowman  and his  colleagues.
      The above findings have been  generally confirmed  and extended by Rice and her colleagues
(Rice,  1984,   1985a,b;   Rice  and  Willes,  1979;   Rice and Gilbert,  1985;  Rice etal.,  1979).
Although  Rice's studies used operant  conditioning tasks to a greater extent  than  Bowman's
studies, impaired  learning ability was consistently demonstrated, even  in some cases  where the
monkeys'  peak blood  lead levels  reached  only 15 |jg/dl and  steady  state levels were  only 11
ug/dl.   Rice  (1985a)  particularly  noted  the  consistency  of her results with   Bushnell  and
                                           12-133

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Bowman's (1979a,b) finding  of  impaired ability to learn discrimination reversal  tasks.   Simi-
lar results were  also  obtained with rats by Driscoll  and Stegner (1976),  but not by Hastings
et al.  (1984) or Rabe et al. (1985).  In addition, a relatively high degree of response  varia-
bility  was  found  in  Rice's  lead-treated monkeys  as  was found  in lead-treated  rats  (Cory-
Slechta et al., 1985;  Cory-Slechta  et  al. ,  1981, 1983; Cory-Slechta and Thompson, 1979; Dietz
et al., 1978).
     Another finding from Rice's  studies  that is consistent with the results of  other studies
is  the  tendency  of  lead-treated  subjects to  respond  excessively or  inappropriately.   For
example, lead-exposed  monkeys  tended to respond more than control subjects during "time-outs"
in operant schedules  when responses were unrewarded (Rice and Willes, 1979).   They also  tended
to have higher response rates and shorter interresponse times on fixed-interval operant  sched-
ules (Rice,  1985b).   Where  the  schedule of  reinforcement required a  low rate  of responding
before  reward  could  be  delivered,  the lead-treated  subjects were  significantly slower than
controls to  learn  the  appropriate pattern of responding  (Rice  and Gilbert,  1985).  Such sub-
jects also made more perseverative errors on  operant "matching-to-sample"  tasks  that required
them to direct their  responses according to stimulus colors (Rice, 1984).
     These  findings  bear  striking resemblence  to  the  results  of  several  studies  of lead-
exposed rats  which,  as  mentioned above,  tended  to respond excessively or  more  rapidly than
controls or  than  conditions of the experiment would have otherwise produced.  Such tendencies
have been  characterized as  "hyper-reactivity"  by  some  investigators   (e.g., Winneke et al.,
1982b).   However,  this concept (not to  be confused with hyperactivity per se) is  only descrip-
tive,  not explanatory.   Speculation about the neural mechanisms responsible for  such behavior
has tended  to focus  on  the  hippocampus,  because of the  behavioral  similarities  with animals
having  experimental  lesions of the  hippocampus  (Petit and Alfano,  1979;  Petit  et al., 1983)
(see also  Sections 12.4.3.2.1 and  12.4.3.5).    It should be noted  that, at  sufficiently high
exposure levels,  increased  response tendencies  give way  to  decreased  responding (e.g., Cory-
Slechta and  Thompson,  1979;  Angel 1  and Weiss, 1982).   Cory-Slechta et al.  (1983) have  argued
that this curvilinear dose-response relationship may be due at least in part to differences in
the time required  for  response rates to  reach  their maximum as a function of different expo-
sure levels.   In  their  study,  rats exposed to  higher concentrations of  lead took longer to
reach their peak response rate; consequently,  assessing performance earlier would make the re-
sponding of the higher lead exposure group appear depressed, while responding of  a lower expo-
sure group would  appear to  be elevated relative  to controls (Cory-Slechta et al., 1983).   Of
course,  at  sufficiently toxic  doses,  responding  obviously  declines  if the subjects  are no
longer able to perform the necessary motor responses.
                                          12-134

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     It  seems  clear  from the  above  studies  that alterations  in the  behavior  of rats  and
monkeys occur as  a  consequence  of chronic exposure to  relatively low levels of dietary lead.
In a number of instances (e.g.,  Mele et al.,  1984; Bushnell  and Bowman, 1979b) these perturba-
tions were  evident  even after blood lead concentrations had returned to nearly normal  levels,
although earlier  exposure  had probably been much higher.   One study reported learning  distur-
bances  in  monkeys whose average  steady-state  blood  lead  level was around  11 pg/dl  and whose
peak  level  reached only  about  15 ug/dl  (Rice,  1985a).   A  number of  studies  with  rats found
evidence of behavioral  deficits at blood lead levels below 30 ug/dl, and in at least one case
the blood lead level probably did not exceed 20 ug/dl.
12.4.3.1.4   Effects of  lead on  socjal behavior.   The social  behavior and organization of even
phylogenetically  closely related species may be widely divergent.  For this and other reasons,
there  is little  or  no basis to  assume  that,  for example,  aggressiveness in a lead-treated
rhesus  monkey   provides a model of  aggressiveness  in  a   lead-exposed human child.  However,
there are other compelling grounds for  including animal social behavior in  the present review.
As  in the  case  of nonsocial behavior patterns,  characteristics  of  an animal's interactions
with  conspecifics may reflect  neurological (especially CNS)  impairment due to toxic exposure.
Also,  certain  aspects of animal  social  behavior have  evolved for the very purpose  (in a non-
teleological  sense) of  indicating  an  individual's  physiological state  or condition   (Davis,
1982).   Such behavior could potentially  provide  a sensitive  and  convenient indicator of toxi-
cological  impairment.
      Two  early reports  (Silbergeld  and Goldberg, 1973;  Sauerhoff and Michael son,  1973) sug-
gested  that lead exposure produced  increased  aggressiveness  in  rodents.  Neither report, how-
ever,  attempted  to  quantify  these observations  of  increased aggression.  Later, Hastings et
al.  (1977) examined aggressive behavior  in rats  that had been exposed to lead via  their dams'
milk.  Solutions  containing 0, 0.01,  or 0.05 percent  lead  as  lead  acetate  constituted the dams'
drinking water from parturition  to  weaning  at PND 21, at which  time exposure was  terminated.
This  lead  treatment produced no  change in growth of the pups.   Individual pairs of male off-
spring (from the same  treatment  groups) were tested at  PND  60  for  shock-elicited  aggression.
Both  lead-exposed groups  (average blood lead levels of 5 and 9  pg/dl and brain lead levels of
8 and 14 ug/lOOg) showed significantly less aggressive  behavior  than  the  control  group.  There
were  no  significant differences among the groups  in  the  flinch/jump  thresholds   for  shock,
which suggests that the  differences  seen in  shock-elicited  aggression were not caused  by  dif-
ferences in sensitivity to shock.
      A study by  Drew  et al.  (1979) utilized  apomorphine to induce aggressive behavior in 90-
day-old rats and found that  earlier lead exposure attenuated the drug-induced aggressiveness.
                                           12-135

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Lead exposure occurred  between  birth and weaning primarily through  the  dams'  milk or through
food containing 0.05  percent  lead as lead acetate.   No blood  or tissue concentrations of lead
were measured.  There were  no significant differences in the  weights  of the  lead-treated and
control animals at PND 10, 20, 30, or 90.
     Using laboratory mice  exposed  as adults, Ogilvie and Martin (1982)  also  observed reduced
levels of aggressive  behavior.   Since the same subjects  showed  no  differences in vitality or
open field activity measures,  the reduction  in aggressiveness did  not appear to be  due  to  a
general effect  of lead  on  motor activity.   Blood  lead levels were estimated  from similarly
treated groups  to be approximately 160 ug/dl  after  2 weeks  of exposure and  101 ug/dl  after
4 weeks of exposure.
     Cutler (1977) used  ethological  methods to assess the effects  of  lead  exposure on social
behavior  in  laboratory  mice.    Subjects  were exposed  from  birth (via their  dams'  milk) and
post-weaning to a 0.05 percent solution of lead as lead acetate (average brain lead concentra-
tions were 2.45 nmol/g for controls and 4.38 nmol/g for experimental subjects).   At 8 weeks of
age social encounters between  subjects from the same treatment group were analyzed in terms of
a number of specified, identifiable behavioral and postural  elements.   The frequency and dura-
tion of certain  social  and sexual investigative behavior patterns were significantly lower in
lead-treated mice of both sexes than in controls.   Lead-exposed males also showed significant-
ly reduced agonistic  behavior compared with  controls.  Overall  activity  levels (nonsocial as
well as  social  behavior) were not  affected  by  the  lead treatment.   Average  body weights did
not differ  for the  experimental  and control subjects  at weaning or at the  time of testing.
     A  more  recent   study  by  Cutler and  coworkers   (Donald  et al.,  1981)  used  a  similar
paradigm of exposure and behavioral evaluation,  except that exposure occurred  either only pre-
natal ly or postnatal ly  and  testing occurred  at two times,  3-4 and 14-16 weeks  of age.   Sta-
tistically significant  effects were  found only  for  the postnatal  exposure  group.  Although
total   activity  in postnatally exposed mice did not differ from that of controls at either age
of testing, the incidence of various social activities did differ significantly.  As juveniles
(3-4 weeks old),  lead-treated males (and to some extent, females) showed decreased social in-
vestigation  of  a  same-sex  conspecific.   This  finding seems   to  be consistent  with Cutler's
(1977) earlier  observations made  at 8 weeks of age.  Aggressive behavior, however, was almost
nonexistent in  both  control and lead-treated subjects in the  later study, and so could not be
compared meaningfully.   Although  the authors do not comment on this aspect of their study, it
seems  likely  that differences in the  strains of  laboratory  mice used as subjects could well
have been  responsible for the lack  of aggressive  behavior  in the Donald et  al.  (1981) study
(see,  e.g., Adams and Boice,  1981).   Later  testing at 14-16  weeks revealed that lead-exposed
female subjects  engaged  in significantly  more investigative  behavior of  a  social or sexual

                                          12-136

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nature  than  did control  subjects,  while males  still  showed  significant  reductions in  such
behavior when  encountering another mouse  of the  same  sex.   This apparent disparity between
male and female mice  is  one of relatively few reports  of gender differences  in sensitivity to
lead's  effects  on  the nervous  system (cf.  Cutler,  1977; Verlangieri, 1979).  In  this  case,
Donald  et  al.  (1981)  hypothesized  that the  disparity might  have been due to  differences  in
brain lead concentrations:   74.7 (jmol/kg  in males versus 191.6 umol/kg in  females  (blood lead
concentrations were not measured).
     The social behavior of rhesus monkeys has also been  evaluated as a function of early lead
exposure.  A study by Allen et al.  (1974) reported persistent perturbations in various  aspects
of the social  behavior of lead-exposed infant and juvenile monkeys, including increased  cling-
ing,  reduced  social  interaction,  and increased  vocalization.   However,  exposure  conditions
varied  considerably  in the course of this  study,  with overt toxicity being  evident as  blood
lead levels at times ranged higher than 500 ug/dl.
     A  more  recent  study consisting of  four experiments (Bushnell  and Bowman,  1979c) also
examined social behavior in infant rhesus monkeys, but under more systematically varied expo-
sure  conditions.   In  experiments  1 and  2,  daily ingestion  of  lead  acetate  during the first
year  of life  resulted in blood  lead  levels of 30-100 pg/dl,  with  consequent suppression of
play  activity,  increased  clinging,  and greater  disruption  of  social behavior when the play
environment was altered.   Experiment 3, a  comparison  of  chronic and acute lead exposure (the
latter  resulting   in  a peak  blood  lead  concentration of 250-300 ug/dl  during weeks  6-7 of
life),  revealed little effect  of  acute  exposure except  in the disruption that occurred when
the  play environment was altered.   Otherwise,  only  the  chronically  exposed  subjects differed
significantly  from controls  in various categories  of social  behavior.   Experiment 4  of the
study  showed  that  prenatal exposure alone,  with  blood lead  concentrations of  exposed infants
ranging between 33 and 98 ug/dl at birth,  produced  no detectable  behavioral  effects under the
same  procedures of  evaluation.   Overall,   neither  aggressiveness nor  dominance  was  clearly
affected by lead exposure.
     Another  aspect of social  behavior--interaction between  mothers and their offspring—was
examined in  lead-exposed  rats  by  Zenick et al.  (1979).    Dams  chronically received up to 400
mg/kg  lead acetate in their  drinking water on  a  restricted daily  schedule (blood  lead concen-
trations averaged  96.14  ± 16.54 ug/dl in  the high-exposure group at  day  1  of  gestation).   Dams
and  their  litters  were videotaped on  PND  1-11,  and the occurrence  of  certain  behavior patterns
(e.g.,  lying  with  majority of pups,  lying away  from  pups, feeding) was tabulated by the  exper-
imenters.   In  addition,  dams were  tested  for  their propensity to retrieve pups removed  from
the  nest.   Neither analysis  revealed significant effects of lead exposure  on the  behavior of
the  dams.  However,  restricted access to  drinking water  (whether lead-treated or not) appeared
to confound  the measures of maternal  behavior.
                                           12-137

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     A more  recent investigation of  maternal  behavior and offspring development in  rats  ex-
posed  via  their food  revealed  significant lead-related alterations in the  behavioral  inter-
actions between pups and their dams (Barrett and Livesey,  1983).   Pups  whose  blood  lead  levels
ranged from  20  to  60  ug/dl  at weaning were  slower  to  leave the  nest area to find  the dam  for
suckling or to climb into food hoppers for solid food.   The lead-exposed dams,  with  blood lead
values of  30-60 ug/dl  at weaning,  in turn  spent more time  in  the nest than control   dams.
These  findings  are consistent  with other observations  of retarded pup  development and  in-
creased retrieval of pups to the nest by dams exposed to low levels of  lead (Davis,  1982).   As
Barrett and  Livesey (1983)  note, the  net effect of this altered  motor-infant  interaction is
difficult to  predict.   While  extra maternal  care could help compensate for slowed  development
caused by lead,  it could also exacerbate  the  situation by depriving the pups of the outside
stimulation needed for normal  development (Levitsky et al., 1975).
     The above  studies  suggest  that animal social behavior or behavioral  interactions  may be
altered in  various ways by  exposure to  lead.   Aggressive  behavior in particular is, if any-
thing, reduced  in  laboratory  animals  as a result of  exposure  to lead.   Certain other aspects
of social behavior in  laboratory mice, namely components  of sexual interaction and  social  in-
vestigation,  also  appear  to be  reduced in lead-treated subjects, although there may be  gender
differences  in  this regard following  chronic post-maturational  exposure.   In  additon,  young
rhesus monkeys  appear  to  be sensitive to the disruptive effects  of lead on various  aspects of
social behavior.   These  alterations in social behavior in  several  mammalian  species are indi-
cative of altered neural functioning as a consequence of lead exposure.
12.4.3.1.5   Persistence of  neonatal exposure  effects.   The  specific question of  persisting,
long-term consequences  of  lead  exposure on  the  developing organism has been addressed in a
number of studies  by  carrying out  behavioral  testing  some  time  after  the termination of lead
exposure.    For  example,  such evidence  of  long-term  effects has been  reported   for  rhesus
monkeys by Bushnell and Bowman  (1979b).   Their subjects were  fed  lead acetate so  as to main-
tain blood  lead levels  of either 50 ±  10 (low-lead)  or 80 ±  10 ug/dl  (high-lead)  throughout
the first year of life (actual means and standard errors for the  year were reported  as 31.71 ±
2.75 and 65.17  ± 6.28 ug/dl).  Lead treatment was terminated at  12 months of age,  after which
blood  lead levels declined to around 5-6 ug/dl at 56 months.  At  49 months of age the subjects
were  re-introduced to a  discrimination  reversal training  procedure using new discriminative
stimuli.    Despite   their  extensive experience  with  the  apparatus (Wisconsin  General  Test
Apparatus) during the first  two years of life, most of the  high-lead subjects failed to  retain
the  simple  motor  pattern (pushing  aside  a  small  wooden  block) required to  operate the  ap-
paratus.   Remedial  training largely corrected this deficit.  However,  both high- and low-lead
groups required  significantly more  trials than the control group (p <0.05) to  reach criterion

                                          12-138

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performance levels.  This  difference  was found only on the first discrimination task and nine
reversals of  it.   Successive  discrimination  problems showed no  differential  performance ef-
fects, which  indicates that with  continued training  the lead-treated subjects were  able to
achieve the same level  of performance as controls.
     Other studies with  monkeys  have also shown behavioral  alterations  some time after blood
lead concentrations have  returned  to essentially normal  levels  (Laughlin  et al., 1983; Levin
and  Bowman,  1983; Mele  et al.,  1984).   Some  evidence  suggests that  rats may  show  similar
effects  (e.g.,  Angell  and Weiss,  1982; Gross-Selbeck  and  Gross-Selbeck, 1981),  but other
evidence implies that  behavioral  effects eventually disappear after lead exposure ends (e.g.,
Flynn et al.,  1979;  Hastings  et al., 1977,  1984; Padich and Zenick, 1977;  Rosen et al., 1985;
Schlipkb'ter and Winneke,  1980).   Even if some  behavioral  changes are reversible, it does not
follow,  of  course, that all behavioral  effects of early  lead exposure  are reversible.  Most
likely, neurotoxic outcomes differ in their persistence, and these differences account for any
apparent inconsistency in the above findings.
12.4.3.2  Morphological Effects
12.4.3.2.1  In vivo studies.  Recent key findings on the morphological effects of i£ vivo lead
exposure on  the nervous system are  summarized  in  Table 12-6.*   It  would  appear that certain
types of of  glial  cells are sensitive  to  lead  exposure,  as Reyners et al. (1979) found a de-
creased density of oligodendrocytes in cerebral cortex of young rats exposed from birth to 0.1
percent  lead  in their  food.  Exposures to higher concentrations  (0.2-0.4 percent lead salts),
especially if  begun  during the prenatal period (Bull et al., 1983), can reduce synaptogenesis
and  retard dendritic  development in the cerebral cortex  (McCauley and Bull, 1978; McCauley et
al.,  1979,  1982)  and  the  hippocampus  of  developing rats (Campbell  et  al.,  1982;  Alfano and
Petit, 1982).   Some  of these effects, e.g.,  those on the hippocampus, appear to be transient
(Campbell  et  al., 1982)  and  may  be related  to lead-induced alterations  in size and/or bio-
availability  of sub-cellular  zinc pools (Sato  et al., 1984).  Interestingly, an apparent com-
pensatory hypertrophy  of both neurons and neuropil  appears in certain areas of the hippocampus
of 90-day old rats who were exposed perinatally to  lead  (Kawamoto et al., 1984).
"Concentrations  of lead  reported in the  following sections  are  given  as percent lead salt.
 For  comparison with  exposure  concentrations discussed  in other  sections  of this document,
 multiply  by  10,000 to obtain value  in parts per million  (ppm).   Example:   1% = 10,000 ppm.
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                 TABLE 12-6.  SUMMARY OF KEY STUDIES OF MORPHOLOGICAL EFFECTS OF IN VIVO LEAD EXPOSURE*
Species
Exposure protocol
Peak blood
lead level
Observed
 effect
                                                            Reference
Young rats
0.1% Pb2* in chow
PND 0-90
               0.1% Pb(Ac)2 in
               dams' drinking
               water PND 0-60

               0.1X Pb(Ac)2 in
               dams' drinking
               water PND 0-32

               0.2% PbCl2 in dams'
               drinking water from
               gestation thru PND 20
               0.2% Pb(Ac)2 1n
               dams' drinking
               water PND 0-25

               0.4% PbC03 in
               dams' drinking
               water PND 0-30
               0.5% Pb(Ac)2 in
               dams' drinking
               water PND 0-21
               1% PbCOa in chow
               PND 0-60
               4% PbC03 in dams'
               chow PND 0-28
                            80 ug/dl
                            (at birth)
                            300-400 ug/dl
                            (PND 26)
                            385 ug/dl
                            (PND 21)
                            258 Mg/dl
                            (PND 28)
                     Decreased density of
                     oligodendrocytes 1n cerebral
                     cortex

                     Focal necrosis of photoreceptor
                     cells and cells In Inner
                     nuclear layer of retina

                     Significant Inhibition In
                     myelin deposition and
                     maturation in whole brain
                     Less mature synaptlc profile
                     in cerebral cortex at PNO 15

                     30% reduction in synaptlc
                     density in cerebral cortex
                     at PND 15 (returned to normal
                     at PND 21)

                     15-30% reduction in
                     synaptic profiles in
                     hippocampus

                     Retardation in temporal
                     sequence of hippocanpal
                     dendritic development
                     10-15% reduction in number
                     of axons 1n optic nerve;
                     skewing of fiber diameters
                     to smaller sizes

                     Retardation of cortical
                     synaptogenesis over and
                     above any nutritional
                     effects

                     13% reduction in
                     cortical thickness
                     and total  brain weight;
                     reduction in synaptlc
                     density
•Abbreviations:

PND:       postnatal day
Pb(Ac)2:  lead acetate
PbC03:    lead carbonate
                              Reyners et al.  (1979).
                              Santos-Anderson et al.
                                (1984)

                              Stephens and
                                Gerber (1981)

                              McCauley and Bull
                                (1978); McCauley
                                et al. (1979)

                              McCauley et al. (1982)
                                                                                     Campbell  et  al.  (1982)
                              Alfano and Petit
                                (1982); Petit et al.
                                (1983)
                              Tennekoon et al.
                                (1979)
                              Averill  and Needleman
                                (1980)
                              Petit and
                              LeBoutilller (1979)
4% PbC03 in dams'
chow PND 0-25
Adult rats 4% PbC03 in chow
for 3 MOS.
4% PbC03 in chow 300 ug/dl
PND 0-150 (PND 150)
Reduction In hippocanpal
length and width; similar
reduction in afferent
projection to hippocampus
Delay in onset and peak
of Schwann cell division
and axonal regrowth in
regenerating nerves
Demyell nation of peri-
pheral nerves beginning
PND 20-35
Alfano et al. (1982)
Ohnishi and
(1981)
Dyck
Wlndebank et al.
(1980)
                                                        12-140

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     Suckling rats subjected to  increasing exposures of lead exhibit more pronounced effects,
such as reduction  in  the number and average diameter  of axons in the optic nerve at 0.5 per-
cent lead  acetate exposure (Tennekoon et  al.,  1979),  a general retardation of  cortical  syn-
aptogenesis at 1.0 percent lead carbonate exposure (Averill  and Needleman, 1980), or a reduc-
tion in  cortical  thickness at  4.0 percent  lead carbonate exposure  (Petit  and  LeBoutillier,
1979).   This  latter  exposure  concentration  also  causes  a  delay  in the  onset and  peak  of
Schwann cell  division and  axonal  regrowth in  regenerating  peripheral  nerves  in chronically
exposed adult rats (Ohnishi  and Dyck, 1981).   In short, both neuronal and glial  components  of
the nervous system appear to be affected by neonatal or chronic lead exposure.
     Organolead compounds have also been demonstrated to have a deleterious effect on the mor-
phological development of  the  nervous system.    Seawright  et  al.  (1980)  administered triethyl
lead  acetate (Et3Pb)  by gavage to  weanling (40-50  g) and  "young  adult"  (120-150  g)  rats.
Single  doses  of 20 mg Et3Pb/kg  caused impaired balance,  convulsions, paralysis,  and coma  in
both groups  of  treated animals.   Peak levels in blood and brain were noted two days after ex-
posure, with  extensive  neuronal  necrosis evident in several  brain regions by three days post-
treatment.   Weekly exposures to  10 mg  Et3Pb/kg for  19  weeks resulted  in  less severe overt
signs  of  intoxication (from which the animals  recovered)  and moderate to severe loss of neu-
rons in the hippocampal  region only.
12.4.3.2.2  In vitro  studies.  Bjorklund et al.  (1980) placed  tissue  grafts  of developing ner-
vous tissue in the anterior eye chambers of adult rats.  When  the host animals were given 1 or
2 percent  lead acetate in  their drinking water,  the  growths of substantia  nigral  and hippocam-
pal,  but not cerebellar,  grafts were retarded.  Grafts of  the developing cerebral  cortex in
host  animals  receiving  2  percent lead  exhibited a  permanent 50 percent  reduction  in size
(volume),  whereas 1  percent lead produced a slight  increase  in size  in  this tissue type.  The
authors  felt that this  anomalous  result might  be  explained by a  hyperplasia of  one particular
cell type  at  lower concentrations  of  lead  exposure.
     Organolead  compounds have  also  been demonstrated  to affect neuronal growth (Grundt et
al.,  1981).   Cultured cells  from  embryonic chick brain were exposed to 3.16 uM  triethyllead
chloride  in  the  incubation medium  for 48  hr, resulting in  a  50 percent reduction in  the  number
of  cells  exhibiting  processes.   There was  no observed effect on glial morphology.
     Other investigations  have  focused on morphological  aspects of  the blood-brain barrier and
its possible disruption by lead  intoxication   (Kolber  et al., 1980).   Capillary endothelial
cells   isolated   from  rat  cerebral  cortex  and exposed  to  100  uM lead  acetate  iji  vitro
 (Silbergeld  et al.,  1980b) were examined by  electron microscopy and X-ray microprobe analysis.
 Lead deposits were found  to  be sequestered preferentially  in the  mitochondria of these cells
 in  much the  same manner as calcium.   This affinity may be  the basis for lead-induced disrup-
 tion of transepithelial  transport of Ca2  and  other ions.
                                           12-141

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12.4.3.3  Electrophysiological Effects.
12.4.3.3.1   In vivo studies.   Recent key  findings  on the electrophysiological effects  of  ir\
vivo lead exposure are  summarized below in Table 12-7.   The  visual  system appears  to be par-
ticularly susceptible  to perturbation  by  neonatal  lead  exposure.   Suckling  rats  whose dams
were given drinking water  containing 0.2 percent lead acetate  had  significant alterations  in
their  visual  evoked  responses  (VERs)  and decreased  visual  acuity  at  PND 21, at  which time
their blood lead levels were 65 ug/dl (Cooper et al.,  1980; Fox et al.,  1977;  Impelman et al. ,
1982;  Fox  and Wright,  1982;  Winneke,   1980).   Both  of these  observations are indicative  of
depressed conduction velocities  in  the  visual pathways.    These  same exposure  levels also in-
creased the  severity of the maximal electroshock seizure  (MES)  response  in weanling rats who
exhibited blood lead levels of 90 ug/dl  (Fox et al.,  1978, 1979).  The authors  speculated that
neonatal lead exposure  acts to increase the  ratio of  excitatory to inhibitory systems in the
developing cerebrospinal  axis.   Such exposure can also  lead  to lasting effects on the  adult
nervous system, as  indicated  by persistent decreases  in  visual  acuity  and spatial  resolution
in 90-day old rats exposed only from birth to weaning to 0.2 percent lead acetate  (Fox et al.,
1982).   A 38-percent decrease in the number  of  cholinergic  receptors in the visual cortex  of
adult  rats treated  in  this manner (Costa and Fox, 1983)  may represent the morphological  basis
for this finding.
     The adult nervous system is also vulnerable to lead-induced perturbation at low levels  of
exposure.   For example, Hietanen et al.  (1980) found that chronic exposure of adult rabbits  to
0.2 percent  lead  acetate in drinking water resulted in an 85 percent inhibition of motor con-
duction velocity  in the sciatic nerve;  adult  rabbits  fed 165 mg lead carbonate per day for 5
days (Kim et al.,  1980) showed a 75 percent increase in Ca2  retention time in incubated brain
slices, indicating that lead inhibits the mediated efflux of Ca2 .
12.4.3.3.2   In vitro studies.   Palmer et al.  (1981) and  Olson  et  al. (1981) looked at intra-
ocular  grafts of  cerebellar tissue from 14-  to  15-day-old rats in host animals treated for 2
months  with  drinking water containing 1 percent lead acetate, followed by plain water for 4-5
months.   They found  no alterations  in total  growth  or  morphology of cerebellar  grafts  in
treated versus control  hosts,  yet the  Purkinje  neurons  in the  lead-exposed grafts had almost
no spontaneous activity.   Host cerebellar neurons, on the other hand, and both host and graft
neurons  in   control  animals,  all  exhibited significant  levels  of  spontaneous activity.   It
should  be  noted  that  when these  investigators  looked at the effects  of  lead on   intraocular
grafts  of  other areas  of  fetal  rat brain, i.e., substantia  nigra,  hippocampus,  and parietal
cortex, they found significant  delays  in  the growth of  these grafts  (Olson et  al. , 1984).
Furthermore, attempts by this group to replicate their findings  ui vivo by using neonatal rats
exposed from gestation  to  PND 20 to 0.5  percent lead acetate in drinking water have been un-
successful (Palmer et al.,  1984).
                                          12-142

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           TABLE 12-7.   SUMMARY OF KEY STUDIES OF ELECTROPHYSIOLOGICAL EFFECTS OF IN VIVO LEAD EXPOSURE*
   Species
  Exposure protocol
Peak blood
lead level
    Observed
     effect
Reference
  Suckling  rat
 I
1—"

to
  Young rhesus
    monkeys
  Adult rabbit
0.2% Pb(Ac)? in
dams' drinking water
PND 0-20

0.2% Pb(Ac)? in
dams' drinking water
PND 0-21
Pb(Ac)2 solutions
in food
PNO 0-365
0.2% Pb(Ac)2 in
drinking water for
4 weeks
90
(PND 20)
                                           65
                                           (PND 21)
300
(PND 60)
85 jjg/dl
More rapid appearance
and increased severity of
MES response

1) Increased latencies and
  decreased amplitudes of
  primary and secondary
  components of VER;
2) decreased conduction
  velocities in visual
  pathways;
3) 25-50% decrease in
  scotopic visual acuity
4) persistent decreases
  in visual acuity and
  spatial resolution at
  PND 90

Severe impairment
of discrimination
accuracy; loss of
scotopic function

85% reduction in motor
conduction velocity of
sciatic nerve
Fox et al.
  (1978, 1979)
                                                    Fox et al.
                                                      (1977);
                                                      Impelman et al.
                                                      (1982);
                                                      Cooper et al.
                                                      (1980);
                                                      Winneke (1980);
                                                      Fox and Wright
                                                      (1982);
                                                      Fox et al.
                                                      (1982)
Bushnell et al.
  (1977)
                                                    Hietanen et al.
                                                      (1980)
  *Abbreviations:

  PNO:      postnatal day

  Pb(Ac)2:  lead acetate
  MES:      maximal electroshock seizure
  VER:      visual evoked  response

-------
     Taylor et  al.  (1978)  recorded  extracellularly from  cerebellar Purkinje cells  in  adult
rats both  ui  situ  and in intraocular grafts in an effort to determine what effect lead had on
the  norepinephrine  (NE)-induced  inhibition of Purkinje cell  spontaneous  discharge.   Applica-
tion of  exogenous  NE  to both rn situ and i_n oculo cerebellum produced 61 and 49  percent  inhi-
bitions of spontaneous  activity,  respectively.   The presence of 5-10 uM lead reduced  this  in-
hibition to  28 and 13  percent,  respectively.   This "disinhibition" was specific for NE,  as
responses to  both  cholinergic  and  parallel fiber stimulation  in  the same tissue remained  the
same.  Furthermore, application  of  lead  itself  did not affect spontaneous  activity,  but  did
inhibit  adenylate  cyclase activity  in  cerebellar  homogenates  at the  same  concentration  re-
quired to disinhibit the NE-induced reduction of spontaneous activity (3-5 uM).
     Fox and  Sillman  (1979) and  Sillman  et  al.  (1982) looked at receptor  potentials in  the
isolated, perfused bullfrog  retina  and  found that  additions  of  lead chloride caused  a rever-
sible, concentration-dependent depression  of  rod (but not cone) receptor potentials.   Concen-
trations as low as  1  uM produced an average  5 percent  depression,  while 25-60 uM produced an
average 34 percent depression.
     Evidence that  lead does  indeed resemble other  divalent cations,  in that  it appears  to
interfere with chemically-mediated synaptic transmission,  has also been obtained  in studies of
peripheral  nerve  function.   For example,  lead  is capable of blocking  neural  transmission  at
peripheral  adrenergic synapses (Cooper  and Steinberg,  1977).   Measurements of the contraction
force  of  the  rabbit  saphenous artery following  stimulation of the  sympathetic  nerve endings
indicated that lead blocks  muscle  contraction by an effect on the nerve terminals rather than
by an  effect  on the muscle.   Since the  response recovered when the Ca2   concentration was  in-
creased  in the bathing  solution,  it  was  concluded  that  lead  does not  deplete  transmitter
stores in  the nerve terminals,  but more likely blocks NE release (Cooper and Steinberg,  1977;
Pickett and Bornstein, 1984; Kober and  Cooper, 1976).
     It has also been  demonstrated that  lead depresses synaptic transmission at the peripheral
neuromuscular  junction  by  impairing acetylcholine (ACh)  release from  presynaptic  terminals
(Kostial  and Vouk,  1957; Manalis and Cooper, 1973; Cooper and Manalis, 1974).  This depression
of neurotransmitter release  evoked  by  nerve stimulation is  accompanied by an increase in  the
spontaneous release of  ACh,  as evidenced  by  the  increased frequency of spontaneous  miniature
endplate potentials (MEPPs) (Atchison and Narahashi, 1984;  Kolton and Yaari (1982) and Manalis
et al. (1984)  found that  this  increase  in MEPPs in the frog nerve/muscle preparation  could be
induced by lead concentrations  as low as 5 uM and is probably due to competitive  inhibition of
Ca2+ binding  (Cooper et al., 1984).
     The effects of lead on neurotransmission within the central nervous system have  also been
studied.   For example,  investigation of the ui vitro effects  of lead on Ca2  binding on cau-
date synaptosomes  was  carried out by Silbergeld and Adler (1978) .  They determined that 50 uM
                                          12-144

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lead caused  an 8-fold  increase  in 45Ca2+  binding and that in both  control  and  lead-treated
preparations the addition of ATP increased binding, while ruthenium red and Ca2+ decreased it.
Further  findings  in  this  series  of  experiments demonstrated  that  lead  inhibits  the  Na+-
stimulated  loss  of  Ca2   by mitochondria and  that blockade  of  dopamine (DA)  uptake  by  5 pM
benztropine reversed the lead-stimulated increase in Ca2"1" uptake by synaptosomes.   The authors
concluded that  lead  affects the  normal mechanisms of Ca2"1" binding and uptake, perhaps by  che-
lating with  DA  in  order to enter the nerve terminal.   By inhibiting the release of Ca2+ bound
to mitochondria there,  lead essentially causes an increase in the Ca2  concentration gradient
across the  nerve terminal  membrane.   As a result, more  Ca2+ would be expected  to  enter the
nerve  terminal  during depolarization, thus effectively  increasing synaptic neurotransmission
at dopaminergic terminals without altering neuronal firing rates.
12.4.3.4   Biochemical  Alterations.   The  majority of  previous investigations  of biochemical
alterations  in  the  nervous system following exposure to lead have focused on perturbations of
various  neurotransmitter  systems,  probably  because of the documentation  extant on the neuro-
physiological and behavioral  roles played by these transmitters.   Recently, however, somewhat
more attention has been centered on the impact of lead exposure on energy metabolism and other
cellular  homeostatic  mechanisms  such as protein  synthesis and  glucose transport.  A signifi-
cant portion of this work has, however, been conducted \r\ vitro.
12.4.3.4.1   In  vivo  studies.   Recent  key findings on the biochemical effects of  in vivo expo-
sure  are summarized  in  Table 12-8.   Although  the majority  of  recent work  has  continued to
focus  on neurotransmitter  function,  it appears  that the mechanisms  of energy metabolism are
also particularly vulnerable to perturbation by lead exposure.  McCauley, Bull,   and coworkers
have demonstrated that exposure  of prenatal rats to 0.02 percent  lead chloride in their dams'
drinking  water  leads to a  marked  reduction in  cytochrome content in cerebral cortex, as  well
as a  possible  uncoupling of energy metabolism.   Although the reduction  in cytochrome content
is  transient and disappears  by  PND  30,  it occurs  at blood  lead levels  as  low as 36 ug/dl
(McCauley and  Bull,  1978; Bull et  al.,  1979);  delays in the development of energy metabolism
may be seen as late as  PND 50 (Bull, 1983).   [See Section 12.2.1.3  for  a discussion of lead
effects  on mitochondrial  function.]
     There  does not appear to be  a selective vulnerability of any particular  neurotransmitter
system to  the effects  of lead exposure.  Pathways  utilizing dopamine  (DA), norepinephrine
(NE),  serotonin  (5-HT),   y-aminobutyric  acid   (GABA),  and  acetylcholine  (ACh)  as  neuro-
transmitters are  all  reported   to be  affected  in  neonatal animals  at  lead-exposure  con-
centrations  of  0.2-2.0 percent lead salts in dams' drinking water  (see  Shellenberger, 1984 for
an  exhaustive  review of  this  literature).  Although  the blood lead  values reported  following
exposure to the  lower lead  concentrations  (0.2-0.25 percent  lead  acetate or lead  chloride)

                                          12-145

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TABLE 12-8.  SUMMARY OF KEY STUDIES ON BIOCHEMICAL EFFECTS OF IN VIVO LEAD EXPOSURE
Subject
Suckling rat
Peak blood
Exposure protocol lead level
0.004% Pb(Ac)2 in
dams' drinking water
PND 0-35
Observed effect
Decline in synthesis and
turnover of striatal DA
Reference
Govoni et al.
(1979,
1980); Memo
et al.
(1980a>
1981)
        0.02% PbCl2 in dams'
        drinking water from
        gestation thru PND
        21
80 ug/dl     1) Transient 30% reduction
(at birth)     in cytochrome content of
36 ug/dl       cerebral cortex;
(PND 21)     2) possible uncoupling of
               energy metabolism
             3) delays in development of
               energy metabolism
        0.2% Pb(Ac)2 in       47 ug/dl
        dams' drinking water  (PND 21)
        PND 0-21
        0.2% Pb(Ac)2 in
        dams' drinking water
        PND 0-20

        0.25% Pb(Ac)2 in
        dams' drinking water
        PND 0-35

        0.25% Pb(Ac)2 in
        dams' drinking water
        PND 0-35
        0.25% Pb(Ac)2 in
        dams' drinking water
        PND 0-35
        0.25% Pb(Ac2) in
        dams' drinking water
        PND 0-56
             1) 23% decrease in NE levels
               of hypothalamus and
               striatum;
             2) increased turnover of
               NE in brainstem

             8% decrease in AChE
             activity in cerebellum
             Decline in synthesis
             and turnover of striatal
             DA

             Increase in DA synthesis
             in frontal cortex and
             nuc.  accumbens(10-30%
             and 35-45%, respectively)
                                McCauley and
                                  Bull
                                  (1978);
                                  McCauley
                                  et al.
                                  (1979);
                                  Bull  et al.
                                  (1979);
                                  Bull  (1983)

                                Goldman et
                                  al.  (1980)
                                Gietzen and
                                  Woolley
                                  (1984)

                                Govoni et al.
                                  (1978a)
                                Govoni et al.
                                  (1979,
                                  1980; Memo
                                  et al.
                                  (1980a,
                                  1981)

1) 50% increase in DA-specific  Lucchi et al.
  binding to striatal             (1981)
  D2 receptors;
2) 33% decrease in DA-specific
  binding to nuc.  accumbens
  D2 receptors

1) Decline in uptake of DA      Missale
  by striated nerve endings       et al.
2) Elevated DA uptake in          (1984)
  nuc. accumbens
                                    12-146

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                     TABLE 12-8.  (continued)
Subject

Peak blood
Exposure protocol lead level
0.25% Pb(Ac)2 71 ug/dl
dams' drinking water (PND 56)
PND 0-56
Observed effect
27% decrease in DA-specific
binding to pituitary D2
receptors
Reference
Govoni et al.
(1984)
0.25% Pb(Ac)2 in      87 ug/dl
dams' drinking water  (PND 42)
PND 0-42
0.25% Pb(Ac)2 in
dams' drinking water
PND 0-21; 0.004% or
0.25% until PND 42
0.5-1% Pb(Ac)2 in
drinking water
PND 0-60
 0.25-1% Pb(Ac)2  in
 drinking water
 PND 0-60
 75 mg Pb(Ac)2/kg
 b.w./day via
 gastric intubation
 PND 2-14
72-91 g/dl
(PND 21)
98
(PND 15)
1) 31% increase in GABA         Govoni  et al,
  specific binding in             (1978b,
  cerebellum; 53% increase        1980)
  in GMP activity;
2) 36% decrease in GABA-
  specific binding in striatum;
  47% decrease in GMP activity

1) 12 and 34% elevation of      Memo et al.
  GABA binding in cerebellum      (1980b)
  for 0.004% and 0.25%,
  respectively;
2) 20 and 45% decreases in
  GABA binding in striatum for
  0.04 and 0.25%, respectively

1) Increased sensitivity        Silbergeld
  to seizures induced             et al.
  by GABA blockers;               (1979,
2) increase  in GABA  synthesis     1980a)
  in cortex  and striatum;
3) inhibition of  GABA  uptake
  and release by  synaptosomes
  from  cerebellum and  basal
  ganglia;
4) 70%  increase  in GABA-
  specific binding in
  cerebellum

1) 40-50% reduction  of         Modak  et al.
  whole-brain ACh by PND  21;       (1978)
2)  36%  reduction  by  PND 30
   (return to normal  values
   by  PND 60)
1)  20%  decline  in striatal      Jason  and
   DA  levels  at PND 35;            Kellogg
 2)  35% decline in striatal         (1981)
   DA  turnover  by PND 35;
 3)  Transient depression of
   DA  uptake  at PND 15;
 4)  Possible  decreased DA
   terminal density
                             12-147

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                                   TABLE 12-8.  (continued)
Subject
Exposure protocol
 Peak blood
lead level
Observed effect
Reference
Young rat     2% Pb(Ac)2 in dams'
              drinking water PND 0-21
              then 0.002-0.008% until
              PND 56
                                  1) non-dose-dependent           Dubas  et al,
                                    elevations of NE in             (1978)
                                    midbrain (60-90%) and
                                    DA and 5-HT in midbrain,
                                    striatum and hypothalamus
                                    (15-30%);
                                  2) non-dose-dependent depression
                                    of NE in hypothalamus and
                                    striatum (20-30%).
*Abbreviations:

PNO:      postnatal day

Pb(Ac)2:   lead acetate
PbCl2:    lead chloride
NE:       norepinephrine
                 DA:      dopamine

                 GABA:    Y~aroinobutyric acid

                 GMP:     guanosine monophosphate

                 5-HT:    serotonin
                              ACh:     acetylcholine

                              AChE:    acetylcholinesterase
                              b.w.:    body weight
range from 47  M9/dl  (Goldman et al., 1980)  to  87 |jg/dl  (Govoni et al.,  1980),  a  few general

observations can be made:


     (1)  Synthesis, turnover, and uptake of DA and NE are depressed in the striatum, and
          elevated in midbrain,  frontal  cortex,  and nucleus accumbens.   This seems to be
          paralleled  by concomitant  increases  in  DA-specific  binding  in  striatum and
          decreases  in  DA-specific  binding  in nucleus  accumbens,  possibly  involving  a
          specific subset (D2) of DA receptors (Lucchi et al., 1981).   These findings are
          probably reflective  of sensitization phenomena  resulting from  changes  in the
          availability of neurotransmitter at the synapse.

     (2)  The  findings  for  pathways  utilizing GABA show similar parallels.  Increases in
          GABA synthesis in  striatum are coupled with decreases in GABA-specific binding
          in that  region,  while  the converse holds  true  for  the  cerebellum.   In these
          cases, cyclic GMP  activity mirrors the apparent changes  in  receptor function.
          This  increased  sensitivity  of cerebellar  postsynaptic  receptors  (probably  a
          response to the  lead-induced  depression of presynaptic function) is likely the
          basis  for  the  finding  that  lead-treated  animals  are  more   susceptible  to
          seizures  induced  by  GABA-blocking  agents  such  as  picrotoxin  or  strychnine
          (Silbergeld et al., 1979).
                                          12-148

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12.4.3.4.2  In vitro studies.   Any alterations in the integrity of the blood-brain barrier  can
have  serious  consequences  for the  nervous  system,  especially  in  the developing  organism.
Kolber et  al.  (1980)  examined glucose transport  in isolated microvessels prepared  from  the
brains of  suckling rats  given 25,  100, 200, or  1000  rag lead/kg body weight daily  by  intra-
gastric gavage.   On PND 25, they found that even the lowest dose blocked  specific  transport
sites for sugars and damaged the capillary endothelium.   In vitro treatment of the preparation
with concentrations of lead as low as 0.1 uM produced the same effects.
     Purdy et al.  (1981)  examined the effects in  rats  of varying concentrations of lead ace-
tate on the whole-brain synthesis of tetrahydrobiopterin (BH4), a cofactor for many important
enzymes,  including  those  regulating  catecholamine (e.g., DA or NE) synthesis.  Concentrations
of lead as  low  as 0.01 uM produced a 35 percent inhibition of BH4 synthesis,  while 100 uM  in-
hibited the BH4  salvage enzyme, dihydropteridine reductase, by 40 percent.   This would result
in a  decreased  conversion of phenylalanine  to tyrosine  and thence to DOPA (the initial steps
in dopamine synthesis),  as well as decreases in  the conversion of trytophan to its 5-hydroxy
form (the initial step in serotonin synthesis).   These decrements, if occurring in vivo, could
not be ameliorated  by increased dietary intake of  BH4,  as it does  not  cross the blood-brain
barrier.
     Lead  has  also been  found to have an  inhibitory effect  on mitochondrial  respiration in
the  cerebrum  and cerebellum  of immature  or adult rats at concentrations  greater than 50 uM
(Holtzman  et  al.,  1978).   This effect, which  was  equivalent  in both  brain regions at both
ages  studied,  is  apparently  due  to  an  inhibition of   nicotinamide adenine  dinucleotide
(NAD)-linked  dehydrogenases within the  mitochondrial  matrix.   These  same  authors found that
this  lead-induced effect, which is an  energy-dependent  process, could be blocked jn vitro by
addition of ruthenium red to  the incubation medium (Holtzman et al., 1980b).  In view of the
fact  that  Ca2   uptake and entry  into the mitochondrial matrix is  also blocked by ruthenium
red,  it is possible that  both  lead and  Ca2+  share the same  binding site/carrier in brain mito-
chondria.  These  findings are  supported by the work  of Gmerek et al.  (1981) on adult rat cere-
bral  mitochondria,  with the exception  that  they  observed respiratory inhibition  at 5 uM lead
acetate,  which  is  a  full  order  of  magnitude  lower than  the  Holtzman et al.  (1978,  1980b)
studies.   Gmerek and co-workers offer  the possibility that this discrepancy  may  have been due
to  the inadvertent presence of EDTA  in the  incubation medium used by  Holtzman and co-workers.
      Organolead  compounds have also been demonstrated to have a  deleterious effect on cellular
metabolism  in the nervous  system.  For example,  Grundt  and Neskovic (1980) found that  concen-
trations of triethyl  lead chloride as  low  as 5-7  uM  caused  a 40  percent  decrease  in  the  incor-
poration  of  S04  or  serine  into  myelin galacto-lipids  in cerebellar  slices from  2-week-old
rats.  Similarly, Konat  and coworkers  (Konat and Clausen,  1978, 1980;  Konat  et  al.,  1979) ob-
serv.ed that 3 uM triethyl  lead chloride preferentially  inhibited the incorporation  of  leucine
                                           12-149

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Into myelin  proteins  in  brain stem and forebrain  slices  from  22-day-old rats.   This  apparent
inhibition of myelin  protein  synthesis was twofold greater than  that  observed  for total  pro-
tein synthesis (approximately 10 versus 20 percent, respectively).   In  addition,  acute intoxi-
cation of these  animals  by i.p. injection of triethyl  lead chloride at 8 mg/kg  produced equi-
valent results accompanied by a 30 percent reduction in total  forebrain myelin content.
     Interestingly, while  a suspension of cells from the  forebrain of  these  animals (Konat et
al., 1978) exhibited a 30 percent inhibition of total  protein  synthesis at 20 uM triethyl  lead
chloride (the lowest concentration examined), a cell-free  system prepared from the  same  tissue
was  not  affected by  triethyl  lead chloride  concentrations as  high as 200  uM.   This result,
coupled with a similar, although not as severe, inhibitory effect of triethyl lead  chloride on
oxygen consumption in the cell suspension (20 percent inhibition at 20  uM) would tend  to indi-
cate that  the inhibition  of  rat forebrain  protein  synthesis  is related to  an  inhibition of
cellular energy-generating systems.
     The effects of  organolead compounds  on various neurotransmitter systems have  been  inves-
tigated in adult mouse brain homogenates.   Bondy et al.  (1979a,b) demonstrated that micromolar
concentrations (5 uM) of tri-n-butyl lead (TBL) acetate were sufficient not only to cause a 50
percent decline  in  the high affinity  uptake  of GABA  and  DA in such homogenates,  but also to
stimulate a  25 percent increase in GABA and DA release.  These effects were  apparently  selec-
tive for DA  neurons  at lower concentrations, as only DA uptake or release was affected  at 0.1
uM, albeit mildly so.  The effect of TBL acetate on DA uptake  appears to be specific,  as there
is  a clear  dose-response relationship down to  1 uM  TBL (Bondy and Agrawal,  1980)  for inhibi-
tion (0-60 percent)  of  spiroperidol  binding  to  rat   striatal  DA receptors.  A  concomitant
inhibition of adenyl  cyclase  in this dose range (50 percent)  suggests  that TBL  may affect the
entire postsynaptic binding site for DA.
12.4.3.5  Accumulation and Retention of Lead in the Brain.  All  too infrequently, experimental
studies  of  the  neurotoxic  effects of  lead  exposure  do  not  report  the  blood-lead  levels
achieved by  the  exposure  protocols  used.   Even less frequently reported  are the  concomitant
tissue levels found in brain or other tissues.  From the recent information that is available,
however,  it  is possible to draw  some limited conclusions about the relationship  of  exposure
concentrations to  blood  and brain lead concentrations.   Table 12-9 calculates the blood lead/
brain  lead  ratios found  in recent studies  where  such information was available.  It  can be
seen that, at exposure concentrations greater than 0.2 percent and for exposure  periods  longer
than birth   until  weaning (21  days  in rats),  the ratio  generally  falls below unity.   This
suggests, that,  even  as  blood lead levels reach a steady state and then fall due to excretion
or  some other mechanism, lead continues to accumulate in brain.
                                          12-150

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TABLE 12-9.  INDEX OF BLOOD LEAD AND BRAIN LEAD LEVELS FOLLOWING EXPOSURE0
Species
(strain)
Suckling rat
(Charles
River-CD)

Suckling rat
(Charles
River)

Suckling rat
(Charles
River-CD)
Suckling rat
(Long- Evans)
Suckling rat
(Long-Evans)
Suckling rat
(Holtzman-
albino)

Suckling rat
Suckling rat
(Holtzman-
albino)
Suckling rat
(Long-Evans)
Exposure
0.0005% PbCl2
in water
PND 0-21
0.003% PbCl2
in water
PND 0-21
0.005% Pb(Ac)2
in water from
conception
0.01% Pb(Ac)2
in water from
conception
0.02% PbCl2
in water
PND 0-21
0.02% Pb(Ac)2
in water
PND 0-21
0.02% Pb(Ac)2
in water from
PND 0-21
0.05% Pb(Ac)2
in water
PND 0-21
0.1% Pb(Ac)2
in water
PND 0-21
0.2% Pb(Ac)2
in water
PND 0-21
0.2% Pb(Ac)2
in water
PND 0-21
0.2% Pb(Ac)2
in water
PND 0-21
Time of Blood lead,
assay ug/dl
PND 21
PND 21
PND 11
PND 30
PND 11
PND 30
PND 21
PND 10
PND 21
PND 21
PND 21
PND 21
PND 21
PND 21
PND 10
PND 21
12
21
22
18
35
48
36
21.7
25.2
29
12
20
65
47
49.6
89.4
Brain lead, Blood: brain
ug/100g lead ratio
8
11
3
11
7
22
25
6.3
13
29
20
50
65
80
19
82
1.5
1.9
7.0
1.6
5.0
2.2
1.4
3.4
1.9
1.0
0.6
0.4
1.0
0.6
2.6
1.1
Reference
Bull et al.
(1979)

Grant et al.
(1980)

Bull et al.
(1979)
Fox et al .
(1979)
Hastings
et al.
(1979)
Goldman
et al.
(1980)

Hastings et
al. (1979)
Goldman
et al.
(1980)
Fox et al .
(1979)
                                12-151

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TABLE 12-9.  (continued)
Species
(strain)
Suckling rat
(Long-Evans)

Suckling rat
(Long-Evans)

Suckling mice
(ICR Swiss
albino)
Suckling rat
(Wistar)




Suckling rat
(Sprague-
Oawley)







Suckling rat
(Wistar albino)





Suckling rat
(Sprague-
Dawley)
Exposure
0.2% Pb(Ac)2
in water
PND 0-21
0.2% Pb(Ac)2
in water
PND 0-21
0.25% Pb(Ac)2
in water
PND 0-21
0.2% Pb(Ac)2
in water
PND 2-60
0.5% Pb(AC)2
in water
PND 2-60
0.25% Pb(Ac)2
in water from
gestation until
PND 42
0.5% Pb(Ac)2
in water
PND 0-21
1% Pb(Ac)2
in water
PND 0-21
0.5% Pb(Ac)2
in diet
PND 0-365




4% PbC03
in water
PND 0-27
Time of Blood lead,
assay ug/dl
PND 21


PND 21


PND 21


PND 30

PND 60
PND 30

PND 60
PND 42



PND 21


PND 21


PND 7
PND 21
PND 35
PND 49
PND 90
PND 180
PND 365
PND 27


65.0


65.1


72


115b
h
35D
308b
k
73D
87



70


91


70
335
291
94
76
78
103
—


Brain lead, Blood: brain
ug/lOOg lead ratio Reference
53


53


230


84

99
172

222
85



280


270


36
127
124
122
123
111
161
1.36


1.2


1.2


0.3


1.4

0.4
1.8

0.3
1.0



0.25


0.3


1.9
2.6
2.3
0.8
0.6
0.7
0.6
___


Fox et al.
(1977)

Cooper
et al.
(1980)
Modak et al.
(1978)

Shigeta
et al.
(1979)



Govoni
et al.
(1980)







MykkSnen et
al. (1979)


MykkSnen et
al. (1982)

Wince et al.
(1980)

     12-152

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                  TABLE 12-9.  (continued)
Species
(strain)
Suckling rat
(Sprague-
Dawley)
Suckling rat
(Long-Evans)




Young mice
(ICR Swiss
albino)





Weanling rats
(Long- Evans)










Adult rat
(Charles
River-CD)
Time of
Exposure assay
0.1 mg/kg Pb(Ac)2 PND 28
by gavage PND 42
PND 3-56 PND 56
25 mg/kg Pb(Ac)2 PND 15
by gavage
PND 2-14
75 mg/kg Pb(Ac)2 PND 15
by gavage
PND 2-14
0.25% Pb(Ac)2 PND 60
in water
PND 0-60
0.5% Pb(Ac)2 PND 60
in water
PND 0-60
1* Pb(Ac)2 PND 60
in water PND 0-60
0.0025% Pb(Ac)2
in water from
PND 22
0.005% Pb(Ac)2
in water from
PND 22
0.01% Pb(Ac)2
in water from
PND 22
0.05% Pb(Ac)2
in water from
PND 22
0.0005% Pb(Ac)2
in water for 21 days

Blood lead,
M9/dl
9.5
13.8
12.7
50


98


91


194


223

18


20


40


100


9


Brain lead,
Mg/ioog
12.1
11.1
10.2
40


60


410


360


810

7


30


50


120


10


Blood: brain
lead ratio
0.78
1.2
1.3
1.3


1.6


0.2


0.5


0.3

2.6


0.7


0.8


0.8


0.9


Reference
Collins et
al. (1984)

Jason and
Kellogg
(1981)



Modak et al.
(1978)






Cory-Slechta
et al.
(1985)









Bull et al.
(1979)

0.003% Pb(Ac)2
in water for 21 days

0.02% Pb(Ac)2
in water for 21 days
11
29
 12
100
0.9
0.3
                        12-153

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                                     TABLE  12-9.   (continued)
Species
(strain)
Adult rat
(Wistar)

0.
in
Exposure
15% Pb(Ac)2
water for 3
Time of
assay
months

Blood lead,
Hg/dl
31

Brain lead,
ng/100g
12-18C
Blood:
lead
2.
brain
ratio
6-1.7c
Reference
Ewers and
Erbe
(1980)
                  0.4% Pb(Ac)2                  69
                  in water for  3 months
                  1% Pb(Ac)2                   122
                  in water for  3 months
16-34C      4.3-2.0c
37-72°      3.3-1.7c
 Abbreviations:
 PND:  post-natal day
 Pb(Ac)2:   lead acetate
 PbCl2:   lead chloride
 Expressed as ug Pb/lOOg blood.
cDepending on region.

     Further evidence bearing on  this  was derived from a  set  of studies by Goldstein et  al.
(1974),  who  reported  that  administration  of a wide range  of doses of radioactive lead nitrate
to  one-month-old rats  resulted  in  parallel  linear increases  in both  blood  and brain  lead
levels during  the ensuing  24  hours.  This suggests that  deposition of lead in  brain  occurs
without threshold  and that, at least  initially,  it  is proportional  to  blood lead  concentra-
tion.  However, further studies  by Goldstein et al.  (1974)  followed changes  in blood and brain
lead concentrations after cessation of lead exposure and found that,  whereas blood lead levels
decreased dramatically  (by an  order of magnitude  or more) during a 7-day  period,  brain lead
levels remained  essentially  constant over the one-week postexposure period.  Thus,  with even
intermittent exposures  to  lead,  it is not  unexpected  that brain concentrations would tend to
remain the  same  or even to increase although  blood  lead  levels may have returned to "normal"
levels.    Evidence  confirming this  comes  from findings of two  studies:  (1) Hammond (1971),
showing that EDTA  administration  causing  marked lead excretion in urine of  young rats did not
significantly  lower  brain  lead  levels in the  same  animals; and (2) Goldstein  et al.  (1974),
showing  that although  EDTA prevented  the i_n vitro  accumulation of  lead into brain  mito-
chondria, if lead was added first EDTA was ineffective  in  removing lead from the mitochondria.
These results,  overall,  indicate  that, although lead  may  enter the  brain in rough proportion
to circulating blood lead concentrations,  it is then taken up by brain cells and tightly bound
into certain subcellular  components (such as mitochondrial membranes)  and  retained there for

                                          12-154

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quite  long  after Initial  external  exposure ceases  and  blood lead levels markedly  decrease.
This may  help to account  for the  persistence of  neurotoxic  effects of various  types  noted
above long after the cessation of external lead exposure.
     The uptake  of  lead  into specific neural  and  non-neuronal elements  of the  brain has also
been  studied  and provides  insight  into  possible morphological  correlates  of certain  lead
effects discussed above  and  below as being observed i_n vivo or i_n vitro.  For  example, Collins
et al.  (1984)  observed preferential  accumulation  of lead  in  the hippocampus  of suckling rats
fed 0.1 mg/kg  Pb(Ac)2  per  day by gastric  intubation from PND 3-56.   In another study, Stumpf
et al.  (1980),  via  autoradiographic localization  of 210Pb,  found that ependymal cells,  glial
cells, and endothelial  cells of brain capillaries concentrate and retain lead above background
levels  for  several  days  after injections  of tracer amounts of the elements.   These cells are
non-neural  elements  of brain important in the maintenance of "blood-brain barrier" functions,
and their uptake and retention of lead, even with  tracer doses, provides evidence of a morpho-
logical basis  by which lead effects on  blood-brain barrier functions may be exerted.  Again,
the retention  of lead  in these non-neuronal elements for at least several days after original
exposure points  towards the plausibility of lead exerting effects on blood-brain barrier func-
tions  long  after external exposure  ceases and blood lead  levels decrease back toward normal
levels.  Uptake  and concentration of lead in  the  nuclei of some  cortical neurons even several
days after  administration  of only a tracer  dose of 210Pb was also observed  by Stumpf et al.
(1980) and provide yet another plausible morphological basis by which neurotoxic effects might
be  exerted  by  lead long after  external  exposure terminates and blood  lead  levels return to
apparently  "normal"  levels.

12.4.4  Integrative  Summary of Human and Animal Studies of Neurotoxicity
     An assessment  of  the  impact of lead on human  and animal neurobehavioral function  raises a
number  of issues.  Among  the  key  points addressed  here  are  the following:   (1) the  internal
exposure  levels, as indexed by blood  lead levels,  at  which various adverse  neurobehavioral
effects occur;  (2)  the reversibility of  such deleterious  effects; and  (3) the populations that
appear  to  be  most  susceptible to  neural  damage.   In addition,  the question  arises as to the
utility of  using animal  studies  to draw parallels  to the  human condition.
12.4.4.1    Internal  Exposure Levels at Which Adverse Neurobehavioral  Effects Occur.    Markedly
elevated  blood lead levels  are  associated with  neurotoxic  effects (including severe,  irrever-
sible  brain damage  as indexed by the occurrence of acute  and/or chronic  encephalopathic symp-
toms)  in both  humans and animals.   For most adult  humans,  such damage  typically does  not occur
until  blood lead levels exceed  120 ug/dl.   Evidence does  exist,  however, for acute  encephalo-
pathy  and death occurring in  some  human adults at  blood  lead levels  below 120 ug/dl, down  to

                                           12-155

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about 100 ug/dl.   In children,  effective  blood lead  levels  for producing  encephalopathy  or
death are  somewhat  lower,  encephalopathy  signs and  symptoms having  been  reported for  some
children at blood lead levels as low as 80-100 ug/dl.
     It should be emphasized that, once encephalopathy occurs, death is not  an improbable  out-
come, regardless  of  the quality of medical  treatment  available  at the time  of  acute  crisis.
In fact, certain  diagnostic or treatment procedures themselves tend to exacerbate matters and
push the outcome  toward fatality if the nature and severity of the problem  are not fully  rec-
ognized or properly  diagnosed.   It is also  crucial to  note the  rapidity with which acute en-
cephalopathic symptoms  can  develop or death can occur  in  apparently asymptomatic individuals
or  in  those  apparently  only mildly  affected  by elevated  body  burdens of  lead.   It  is  not
unusual  for rapid deterioration to occur, with convulsions or coma suddenly  appearing and  with
progression to  death within 48 hours.  This strongly suggests that, even in apparently asymp-
tomatic individuals,  rather severe  neural  damage probably  exists  at  high  blood  lead levels
although such damage is not yet overtly manifested in obvious encephalopathic symptoms.  This
conclusion is further supported by numerous studies showing that children with high blood  lead
levels  (over 80-100  ug/dl), but not  observed to manifest  acute  encephalopathic symptoms, are
permanently cognitively impaired, as  are  most children  who  survive  acute  episodes  of frank
lead encephalopathy.
     Growing  evidence  indicates  that subencephalopathic  lead  intoxication  in  adults causes
various overt  neurological   signs  and symptoms at  blood lead levels  as  low (40-60 ug/dl)  as
those at which  other overt  manifestations (e.g., gastrointestinal symptoms) of lead intoxica-
tion  have been  detected.   In  addition,   among  apparently  asymptomatic,   non-overtly lead-
intoxicated adults,  often  more  subtle (but important) central and  peripheral  nervous system
effects, e.g. slowed nerve  conduction velocities,  have been  observed  at blood lead levels as
low as 30 ug/dl.
     Other evidence   confirms  that various  types  of neural  dysfunction exist  in apparently
asymptomatic children across a broad range of blood lead levels.   The body of studies on  low-
or moderate-level lead effects on neurobehavioral functions, as summarized in Table 12-2,  pre-
sents a rather  impressive array of data pointing to that conclusion.  At high exposure  levels,
several studies point  to average 5-point  IQ  decrements  in  asymptomatic children at average
blood levels of 50-70 ug/dl.  Other evidence is indicative  of average IQ decrements of up to
4 points being  associated with blood levels in a 30-50 ug/dl range.  Below 30 ug/dl, the  evi-
dence for  IQ  decrements is  mixed, with  some studies  showing no significant associations  with
lead once  other  confounding factors  are controlled.   Still, the 1-2  point  differences in IQ
generally  seen  with  blood  lead  levels  in  the  15-30 ug/dl  range are suggestive  of small  lead
effects that are  typically  dwarfed by other social factors.  Moreover, the highly significant

                                          12-156

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linear relationship between IQ and blood lead over the range of 6 to 47 ug/dl  found in low-SES
Black children  indicates that  IQ  effects may  be detected without evident threshold  even  at
these low  levels,  at  least  in this  population of  children.   In addition,  other behavioral
(e.g., reaction time, psychomotor performance) and electrophysiological (altered EEG patterns,
evoked potential measures, and peripheral nerve conduction velocities) are consistent with a
dose-response function  relating neurotoxic  effects  to  lead exposure  levels  as  low as 15-30
|jg/dl and  possibly  lower.   Although  the comparability of  blood lead concentrations across
species  is  uncertain (see discussion below), animal studies  show  neurobehavioral  effects  in
rats  and  monkeys  at  maximal  blood  lead   levels  below 20 pg/dl;  some  studies  demonstrate
residual effects long  after  lead exposure has  terminated  and  blood lead levels have returned
to approximately normal levels.
     Timing,  type,  and duration  of exposure are  important factors in both  animal and human
studies.  It  is  often  uncertain whether  observed  blood  lead  levels represent the  levels that
were  responsible for observed behavioral deficits.  Monitoring of lead exposures in pediatric
subjects in  all  cases  has been highly  intermittent or  non-existent during the period of life
preceding neurobehavioral assessment.  In most studies of children, only one or two blood lead
values  are  provided per  subject.   Tooth lead may be an important  cumulative exposure index;
but  its modest, highly  variable  correlation to blood lead, FEP,  or external exposure levels
makes findings  from various  studies difficult to  compare  quantitatively.  The complexity of
the  many important covariates and  their  interaction with dependent measures of modest validi-
ty,  e.g.,   IQ tests,  may also  account  for many  of the  discrepancies  among  the different
studies.
      The precise medical  or  health significance  of the  neuropsychological  and electrophysio-
logical  effects associated with  low-level  lead exposure as reported  in  the  above studies is
difficult  to state  with  confidence at this time.  Observed IQ  deficits  and  other behavioral
changes,  although  statistically  significant in some studies,  tend  to be relatively  small  as
reported by  the investigators,  but  nevertheless may  still affect  the intellectual  development,
school  performance,  and  social  development of the  affected  children  sufficiently to be regard-
ed  as adverse.  This  would  be especially  true  if  such impaired intellectual development or
school  performance and disrupted social  development  were  reflective of persisting,  long-term
effects  of  low-level lead exposure  in  early childhood.   Although the  issue  of persistence of
such lead  effects  remains  to be  more clearly  resolved,  some  study  results reviewed above
suggest that  significant  low-level  lead-induced  neurobehavioral  and  electrophysiological
effects may, in fact,  persist  at  least  into later childhood.  Animal  studies also demonstrate
long-term  neurobehavioral effects  of relatively  moderate-  or  low-level  lead exposure, even
after blood  lead concentrations have  dropped to nearly normal  levels.

                                           12-157

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12.4.4.2  The Question of Irreversibility.   Little  research  on humans is available on persis-
tence  of  effects.   Some work  suggests  the  possibility of reversing mild  forms  of peripheral
neuropathy in lead workers,  but little is known regarding the reversibility of lead effects on
central nervous  system function  in humans.   A  series of studies on a  group of lead-exposed
children  indicate  persistent  relationships  between blood lead  and  altered slow wave cortical
potentials at two- and five-year follow-ups.  However,  IQ deficits  in  the same group of sub-
jects  were no  longer evident at the  five-year follow-up.   Some work suggests that other mea-
sures  of  classroom performance  may be more  sensitive indicators of lead-induced effects in
older  children.   Prospective  longitudinal  studies  on the  developmental effects  of  lead are
needed to answer  questions  on the persistence or reversibility of neurotoxic effects of early
lead exposure.
     Various animal  studies  provide evidence that alterations in neurobehavioral function may
be  long-lived, with  such  alterations being evident long after blood lead levels have returned
to control levels.  These persistent effects have been demonstrated in monkeys as well as rats
under a variety of learning performance test paradigms.  Such results are also consistent with
morphological,  electrophysiological,  and  biochemical  studies on  animals  that suggest lasting
changes in  synaptogenesis,  dendritic  development,  myelin  and  fiber tract  formation,  ionic
mechanisms of neurotransmission, and energy metabolism.
12.4.4.3   Early  Development and Susceptibility to Neural  Damage.    On  the  question  of  early
childhood vulnerability, the  neurobehavioral  data are consistent with morphological  and bio-
chemical  studies  of the  susceptibility of  the  heme  biosynthetic pathway  to perturbation by
lead. Various lines of evidence suggest that the order of susceptibility to neurotoxic effects
of  lead is:  young > adult, and female > male.  Animal studies also have pointed to the peri-
natal  period of  ontogeny  as a particularly critical time for a variety of reasons:  (1) it is
a period  of  rapid  development of the nervous  system;  (2) it is a period where good nutrition
is particularly critical; and (3)  it is a  period where  the caregiver environment is vital to
normal development. However, the precise boundaries of a critical  period for lead exposure are
not  yet  clear  and  may vary depending on the  species  and function or endpoint  that  is being
assessed.   One analysis of  lead-exposed children suggests that differing effects on cognitive
performance may be a function of the different ages at which children are subjected to neuro-
toxic  exposures.   Nevertheless, there  is  general  agreement that human  infants and toddlers
below  the  age  of  three  years  are  at special  risk because of jm utero  exposure,  increased
opportunity for exposure because  of normal  mouthing behavior  of  lead-containing objects, and
increased  rates  of lead absorption due to  various factors,  e.g.,  iron and  calcium defici-
encies.
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12.4.4.4  Utility of Animal  Studies in Drawing Parallels to the Human Condition.   Animal mod-
els are used  to  shed light on questions where  it would be impractical  or ethically  unaccept-
able to use  human  subjects.   This is particularly true in the case of exposure to  environmen-
tal toxins such  as  lead.   In the  case  of  lead,  it has been  most  effective  and convenient  to
expose developing animals via their mothers'  milk or  by  gastric gavage,  at  least  until  wean-
ing.  Very often, the exposure is continued in the water or food for some  time beyond weaning.
This approach  does  succeed  in simulating at  least two features commonly  found in  human expo-
sure:   oral  intake  and exposure during early development.  The preweaning postnatal  period  in
rats and  mice is of particular relevance in terms of parallels with the first two  years or  so
of human brain development.
     Studies  using  rodents  and monkeys have provided a variety of evidence of neurobehavioral
alteration  induced  by  lead  exposure.   In  most cases  these  effects  suggest  impairment  in
"learning,"  i.e.,  the  process of appropriately modifying one's behavior in response to infor-
mation  from the environment.   Such  behavior  involves the ability  to receive, process,  and
remember  information in various forms.  Some studies indicate behavioral alterations of a more
basic  type,  such as delayed development of certain reflexes.   Other evidence suggests changes
affecting rather complex behavior  in  the form of  social interactions.
     Most  of  the  above effects  are evident  in  rodents and  monkeys  with blood  lead levels
exceeding  30 ug/dl, but some  effects on learning ability are  apparent even  at maximum blood
lead  exposure  levels  below  20 ug/dl.   Can  these  findings  with  animals be  generalized  to
humans?   Given differences  between humans, rats, and  monkeys in heme chemistry,  metabolism,
and  other aspects  of  physiology  and anatomy, it is  difficult  to  state what constitutes  an
equivalent  internal exposure level,  much less  an equivalent external   exposure  level (see
Hammond  et al.  (1985)  for a discussion of  this).   For example,  is a  blood  lead  level of  30
ug/dl  in  a suckling rat equivalent to  30 ug/dl  in a three-year-old  child?  Until an  answer is
available for this question,  i.e.,  until the function describing the  relationship of  exposure
indices  in different  species is  available,  the utility  of  animal  models for deriving dose-
response  functions  relevant  to humans will  be limited.
     Questions also exist  regarding the comparability of neurobehavioral effects  in  animals
with  human behavior and cognitive function.   One difficulty  in comparing behavioral  endpoints
such  as  locomotor  activity  is the lack of  a consistent operational definition.   In  addition to
the lack of  standardized methodologies,  behavior is notoriously difficult to "equate" or com-
pare  meaningfully  across  species  because  behavioral  analogies do  not demonstrate  behavioral
homologies.   Thus,  it  is  improper to assume,  without knowing  more about the  responsible under-
lying  neurological  structures and  processes,  that  a  rat's  performance  on  an  operant condi-
tioning  schedule  or  a monkey's  performance on a stimulus discrimination  task  necessarily
corresponds  directly  to  a  child's performance  on  a  cognitive  function test.   Nevertheless,
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interesting parallels in  hyper-reactivity  and increased response variability do exist between
different  species,  and  deficits  in  performance by  mammalian animals  on  various tasks  are
probably  indicative  of  altered CNS  functions, which  are  likely to  parallel  some type  of
altered CNS function in humans as well.
     In  terms  of morphological  findings,  there are  reports of  hippocampal  lesions in  both
lead-exposed rats and humans that are consistent with a number of independent behavioral  find-
ings  suggesting  an  impaired ability to  respond appropriately  to altered  contingencies  for
rewards.   That  is,  subjects  with  hippocampal  damage  tend to persist  in certain  patterns  of
behavior even when  changed  conditions make the behavior  inappropriate;  the same sort of ten-
dency seems to be common to a number of lead-induced behavioral effects, including deficits in
passive avoidance, operant extinction, visual  discrimination, and various other discrimination
reversal tasks.   Other morphological findings  in animals, such as demyelination and glial cell
decline, are comparable to human neuropathologic observations only at relatively high exposure
levels.
     Another neurobehavioral  endpoint of  interest  in comparing human and animal neurotoxicity
of lead is electrophysiological function.   Alterations of electroencephalographic patterns and
cortical slow wave  voltage  have been reported for  lead-exposed children, and various electro-
physiological alterations  both iji  vivo  (e.g.,  in  rat visual  evoked  response) and  in  vitro
(e.g.,  in frog  miniature  endplate  potentials)  have  also been  noted  in laboratory  animals.
Thus, far,  however,  these lines of work have  not  converged  sufficiently to allow for much in
the  way  of definitive  conclusions  regarding  electrophysiological  aspects  of  lead  neuro-
toxicity.
     Biochemical  approaches  to the experimental study  of lead effects  on  the nervous  system
have  been  basically limited  to  laboratory animal  subjects.   Although  their  linkage  to  human
neurobehavioral   function  is  at this  point somewhat speculative, such  studies  do  provide in-
sight on  possible  neurochemical  intermediaries of  lead  neurotoxicity.   No  single neurotrans-
mitter  system  has been  shown to be  particularly  sensitive  to the effects  of lead exposure;
lead-induced  alterations  have  been  demonstrated  in   various  neurotransmitters,  including
dopamine,  norepinephrine, serotonin,  and  gamma-aminobutyric  acid.   In addition, lead has been
shown to  have subcellular effects in the central nervous system at the level of mitochondrial
function  and protein synthesis.  In  particular, some work has indicated that delays seen in
cortical  synaptogenesis  and  metabolic maturation  following  prenatal  lead  exposure  may well
underlie the delayed development of exploratory and locomotor function seen in other studies of
the  neurobehavioral  effects  of lead.   Further  studies  on the correlation between human blood
lead values  and  lead-induced disruptions  of tetrahydrobiopterin metabolism indicate that sub-
sequent  interference with  neurotransmitter formation  may be  linked  to small  reductions in
IQ scores.
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     Given the  difficulties  in  formulating  a comparative basis for  internal  exposure  levels
among  different species,  the  primary  value  of  many animal  studies,  particularly  HI  vitro
studies,  may  be  in  the information  they can  provide  on basic  mechanisms  involved in  lead
neurotoxicity.   A number of  key i_n vitro studies  are summarized in Table 12-10.   These  stu-
dies show  that  significant,  potentially deleterious  effects on  nervous  system function occur
at i_n  situ lead concentrations of 5 uM  and  possibly lower.   This suggests that,  at least in-
tracellularly or  on a molecular  level,  there may exist essentially  no  threshold  for certain
neurochemical  effects  of  lead.   The  relationship between blood lead levels  and  lead concen-
trations at extra- or intracellular sites of action,  however, remains to be determined.
     Despite the  problems  in  generalizing  from  animals  to humans,  both the  animal  and the
human  studies  show considerable  internal  consistency in that they  both support  a continuous
dose-response functional relationship  between lead and neurotoxic biochemical, morphological,
electrophysiological, and  behavioral effects.
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                             TABLE  12-10.   SUMMARY OF KEY STUDIES OF  IN VITRO  LEAD EXPOSURE*
        Preparation
                                  Exposure
                                concentration
                                     Results
                                Reference
ro
i
ro
     Adult rat  brain


     Isolated microvessels
        from  rat brain

     Adult mouse
        brain homogenate
     Adult  rat  striatum
Embryonic chick
  brain cell culture
Brainstem and forebrain
  slices from PND-22 rats
      Adult rat
        cerebellar homogenates

      Adult rat
        cerebellar mitochondria

      Adult frog
        nerve/muscle preparation
      Isolated,  perfused
        bullfrog retina
0.1 MM Pb(Ac)2


0.1 uM Pb(Ac)2



0.1-5 pM TBL




1-5 MM TBL



3 MM (Et3Pb)Cl2


3 MM (Et3Pb)Cl2




3-5 MM Pb2*


5 MM Pb(Ac)2


5 MM Pb2+




5 MM Pb2+
35% inhibition of whole-
brain BH4 synthesis

Blockade of sugar-specific
transport sites in capil-
lary endothelial cells
1) 50% decline in high
  affinity uptake of DA;
2) 25% increase in
  release of DA

0-60% inhibition of spiro-
peridal binding to DA
receptors

50% reduction in no. of
cells exhibiting processes
Inhibition of leucine in-
corporation into myelin
proteins

Inhibition of adenylate
cyclase activity

Inhibition of respiration


Increase in frequency of
MEPP's (indicative of
depression of synaptic
transmission)

Depression of rod (but not
cone) receptor potentials
                                                                                          Purdy et al.
                                                                                            (1981)

                                                                                          Kolber et al.
                                                                                            (1980)

                                                                                          Bondy et al.
                                                                                            (1979a,b)
Bondy and Agrawal
  (1980)


Grundt et al.
  (1981)

Konat and Clausen
  (1978, 1980);
  Konat et al.
  (1979)

Taylor et al.
  (1978)

Gmerek et al.
  (1981)

Kolton and Yaari
  (1982)
                                                                                          Fox and Si 11man
                                                                                            (1979)

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                                                TABLE 12-10.   (continued)
       Preparation
    Exposure
  concentration
       Results
  Reference
ro
Cerebellar slices
  from PND-14 rats

In oculo culture of
  cerebellar tissue
  from PND-15 rats

Cell suspension from
  forebrain of PND-22 rats
Adult rat cerebral            50
  and cerebellar mitochondria
Adult rat caudate
  synaptosomes
                                   5-7 uM (Et3Pb)Cl2


                                   5-10 uM Pb2+




                                   20 uM (Et3Pb)Cl2


                                         Pb(Ac)2

                                   50 uM PbCl2
     Capillary endothelial
       cells  from rat cere-
       cortex
100 MM Pb(Ac)2
                              Inhibition of incorporation
                              of S04 and serine into
                              myelin galactolipids

                              "Disinhibition" of NE-
                              induced inhibition of
                              spontaneous activity in
                              Purkinje cells

                              30% inhibition of total
                              protein synthesis
                              Inhibition of respiration
8-fold+increase in binding
of Ca2  to mitochondria
(effectively increases
Ca2  gradient across ter-
minal membrane, thus in-
creasing synaptic trans-
mission without altering
firing rates)
Pb preferentially seques-
tered in mitochondria like
Ca2  (possible basis for
Pb-induced disruption of
transmembrane Ca2  transport)
                              Grundt and
                                Neskovic (1980)


                              Taylor et al.
                                (1978)
Konat et al.
  (1978)
Holtzman et al.
  (1978, 1980b)

Silbergeld and
  Adler (1978)
Silbergeld et al.
  (1980b)
     *Abbreviations:

     PND:      postnatal  day
     Pb(Ac)2:  lead acetate
     PbCl2:    lead chloride
     Et3Pb:    triethyl  lead
     TBL:      tri-n-butyl  lead
     DA:       dopamine
     NE:       norepinephrine
     BH4:      tetrahydrobiopterin
     MEPP's:   miniature  endplate potentials

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12.5  EFFECTS OF LEAD ON THE KIDNEY
12.5.1  Historical Aspects
     The  first  description of renal  disease  due  to lead was published  by  Lancereaux (1862).
In a painter  with lead encephalopathy and gout,  Lancereaux  noted tubulo-interstitial disease
of the  kidneys  at autopsy.  Distinctions between glomerular  and  tubulo-interstitial  forms of
kidney  disease  were not,  however,  clearly defined  in the mid-nineteenth  century.   Ollivier
(1863)  reported  observations  in  37 cases of lead poisoning with renal disease and thus intro-
duced  the idea  that  lead nephropathy was a proteinuric disease,  a confusion  with primary
glomerular disease  that persisted  for over  a  century.   Under the  leadership  of Jean Martin
Charcot,  interstitial  nephritis  characterized by  meager proteinuria  in lead poisoning  was
widely  publicized  (Charcot,  1874;  Charcot and  Gombault,  1881)  but  not  always  appreciated by
contemporary physicians (Danjoy,  1864; Geppert, 1882; Lorimer, 1886).
     More than  ninety years  ago,  the English toxicologist Oliver  (1885,  1891) distinguished
acute  effects of  lead on the  kidney from  lead-induced chronic  nephropathy.   Acute  renal
effects of lead  were seen in persons  dying of  lead poisoning and were  usually restricted to
non-specific  changes  in the  renal  proximal  tubular  lining cells.    Oliver  noted that a "true
interstitial  nephritis" developed later,  often with glomerular involvement.
     In an extensive review of the earlier literature,  Pejic  (1928) emphasized that changes in
the proximal  tubules, rather than  the vascular  changes  often referred  to  in  earlier studies
(Gull  and Sutton,  1872),  constitute the  primary injury to the kidney in lead poisoning.   Many
subsequent studies  have shown pathological  alterations in the  renal  tubule with onset during
the early or  acute  phase of lead  intoxication.   These include  the formation  of  inclusion
bodies  in nuclei  of proximal  tubular cells  (Blackman,  1936)  and the development of functional
defects  as  well  as  ultrastructural  changes, particularly  in  renal   tubular mitochondria.
Wedeen  (1984) has  extensively reviewed the  history  of lead poisoning and its relationship to
kidney disease.

12.5.2  Lead Nephropathy in Childhood
     Dysfunction of the proximal  tubule was  first noted as glycosuria in the absence of hyper-
glycemia  in  childhood pica  (McKhann and Vogt, 1926).   Later it was shown  that  the  proximal
tubule transport defect included aminoaciduria (Wilson et al., 1953).   Subsequently, Chisolm
et al.  (1955) found  that  the full  Fanconi  syndrome was  present:   glycosuria,  aminoaciduria,
phosphaturia  (with  hypophosphatemia), and  rickets.    Proximal  tubular  transport  defects  ap-
peared only  when blood lead levels exceeded  80 ug/dl.  Generalized aminoaciduria was seen more
consistently  in  Chisolm's (1962, 1968)  studies  than were other manifestations of renal  dys-
function.   The condition  was  related to  the  severity  of  clinical  toxicity, with the complete
Fanconi syndrome occurring in encephalopathic  children when blood lead concentrations exceeded
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150 ug/dl  (National  Academy of Sciences, 1972).  Children who  were under three years of  age
excreted 4-8.9 mg  of lead chelate during the  first  day of  therapy with CaNa2EDTA  at  75 mg/kg
per day.  The  aminoaciduria disappeared  after treatment with  chelating agents and  clinical
remission of other symptoms of lead toxicity  (Chisolm,  1962).   This  is an important  observa-
tion relative to the long-term or chronic effects of lead on the kidney.
     In a  group  of children with slight  lead-related  neurological  signs reported  by  Pueschel
et al.  (1972),  generalized aminoaciduria was found in 8 of 43 children with blood  lead levels
of 40-120  ug/dl.   Blood lead values in  the  children with aminoaciduria were not specifically
provided  but  presumably were among the  highest  found.   It  should be  noted  that the  children
reported to  have  aminoaciduria in this  study  were  selected  because of a  blood  lead  level  of
£50 ug/dl or a provocative  chelation test of >500 pg of lead chelate per 24 hours.
     Although  children are  considered generally to  be more susceptible  than adults to  the
toxic effects of lead, the  relatively  sparse literature on childhood lead nephropathy probably
reflects  a  greater clinical concern with the  life-threatening neurologic symptoms of lead in-
toxication than with the  transient Fanconi syndrome.

12.5.3  Lead Nephropathy  in Adults
     There  are various  lines  of evidence  in  the literature that prolonged lead  exposure in
humans  can result in chronic  lead  nephropathy in adults.  This evidence  is reviewed below in
terms  of  six major  categories:   (1) lead nephropathy  following  childhood  lead poisoning; (2)
"moonshine"  lead  nephropathy;  (3)  occupational  lead  nephropathy;  (4) lead and gouty nephro-
pathy;  (5)  lead and  hypertensive  nephrosclerosis; and  (6) general  population studies.
     Although  a variety  of methods have been used to assess  body burdens  of lead,  the EDTA
lead-mobilization  test has  emerged as the  most reliable index  of  cumulative  lead stores (see
Chapter 10, Section 10.3.3).   The  reliability of this  test  is apparent under various condi-
tions.    For   example,   Leckie  and  Tompsett  (1958)  showed  that  increasing  the dosage  of
CaNa2EDTA above 2  g/day intravenously  had little  effect on the  amount  of lead  chelate  excreted
by adults.   They  observed little  difference in chelatable lead  excretion when  1  g was  compared
with  2 g intravenously.   Similarly, the magnitude  of  lead chelated when 1 g is  given  intrave-
nously or  2 g  intramuscularly (over  12 hr)  appears  to be  the same  (Albahary et al. , 1961;
Emmerson,  1963; Wedeen et  al.,  1975).   Adult control  subjects without undue  lead absorption
excrete less  than 650 |jg lead  chelate  during the  first post-injection  day if renal function  is
normal, or over four days if renal  function is severely reduced.  Thus, in adults, urinary ex-
cretion  of  lead  chelate  in excess of  about  600  ug  over one  or more  days  following 1-3 g
CaNa2EDTA administered  intravenously  or intramuscularly is  considered indicative  of  excessive
past lead absorption.   The level of reduction of glomerular filtration rate at which the EDTA

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lead-mobilization test is  no  longer reliable has not been  precisely  defined  but  probably  ex-
ceeds a reduction of  85  percent (serum creatinine concentrations in excess  of about  6 mg/dl).
12.5.3.1    Lead  Nephropathy Following  Childhood  Lead Poisoning.    Reports  from   Queensland,
Australia (Gibson et  al.,  1893;  Nye, 1933; Henderson,  1954; Emmerson,  1963) point to a  strong
association  between  severe  childhood  lead  poisoning  (including  central   nervous   system
symptoms) and chronic  nephritis  in early adulthood.   The Australian  children sustained acute
lead poisoning  because the houses  around Brisbane were  painted with  white  lead,  which  the
children ingested by  direct contamination of their fingers  or by drinking lead-sweetened rain
water as it flowed over the weathered surfaces.   Two  fingers brushed against the powdery paint
were shown to pick up about 2  mg of lead (Murray, 1939).   Henderson  (1954) followed up 401  un-
treated children who  had  been diagnosed as having lead poisoning in Brisbane  between 1915  and
1935.  Of these  401  subjects, death certificates revealed  that  165 had died  under the  age of
40,  108 from  nephritis or hypertension.   This is greatly  in excess  of expected probabilities.
Information was  obtained  from 101 of the 187 survivors,  and 17 of these had hypertension and/
or albuminuria.
     The Australian investigators  also established  the validity of  the EDTA lead-mobilization
test for  the detection of excessive  past  lead  absorption  and  further  demonstrated that  the
body lead stores were retained primarily in bone  (Emmerson,  1963;  Henderson, 1954;  Inglis et
al., 1978).   Bone lead concentrations averaged 94 ug/g  wet weight in the young adults dying of
lead nephropathy in Australia  (Henderson and Inglis,  1957; Inglis et al., 1978), compared with
mean values ranging  from 14 to  23 ug/g wet  weight  in bones  from  non-exposed  individuals
(Barry, 1975; Emmerson, 1963;  Gross et al., 1975; Wedeen,  1982).
     Attempts to confirm  the relationship  between  childhood  lead intoxication   and chronic
nephropathy  have not  been successful  in  at least two  studies in  the United States.   Most
children in  the  United States who suffer from overt lead toxicity  do  so early in childhood,
between the ages of 1 and 4, the source often being oral  ingestion of flecks of wall  paint  and
plaster containing lead.   Tepper (1963)  found no evidence  of  increased chronic renal disease
in  139  persons  with  a well-documented  history  of childhood plumbism  20-35  years earlier at
the  Boston  Children's  Hospital.   The total study population comprised 165 patients (after  re-
view of 524 case records)  who  met any two of the following criteria:  1) a definite history of
pica or use of lead nipple shields; 2) X-ray evidence  of lead-induced skeletal alterations; or
3) characteristic symptoms  of lead toxicity.  No uniform objective  measure of lead absorption
was  reported.  In 42  of  the  139  subjects  in question,  clinical  tests  of  renal function were
performed and included urinalysis,  endogenous creatinine clearance, urine culture, urine con-
centrating  ability, 24-hour protein excretion,  and phenolsulfonphthalein excretion.  Only  one
patient was  believed  to  have  died of lead nephropathy; three with creatinine  clearances under
90 ml/min were said to have had inadequate urine collections.  Insufficient details concerning
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past lead  absorption and patient  selection were  provided  to permit  generalized  conclusions
from this report.
     Chisolm et al.  (1976)  also found no evidence of renal  disease in 55 adolescents known to
have been  treated  for  lead  intoxication 11-16 years earlier.   This U.S.  study was  carried out
on  adolescents  between 12  and  22  years of age  in the late 1960s.  During  acute  toxicity in
early childhood, blood  lead levels had ranged from 100 to 650 ug/dl;  all had received immedi-
ate chelation therapy.   Follow-up chelation tests performed with 1 g EDTA i.m. (with procaine)
approximately a decade later resulted in 24-hour lead-chelate excretion of less than 600 ug in
45  of  52 adolescents.   Thus, an important  distinction between the Australian group and those
patients in the United States studied by Chisolm et al. (1976) is that none of the latter sub-
jects  showed  evidence of  increased residual  body lead  burden  by the EDTA  lead-mobilization
test.   The absence of renal disease (as judged by routine urinalysis, blood  serum urea nitro-
gen, serum uric acid,  and  creatinine clearance) led Chisolm et al. to suggest that  lead toxi-
city  in the Australian  children may  have  been of  a  different  type, with a more  protracted
course  than that experienced by the  American  children.  On the  other hand,  chelation therapy
of  the  American children may have  removed  lead stored in bone and  thus  prevented the develop-
ment of renal  failure  later in  life.
12.5.3.2  "Moonshine" Lead Nephropathy.   In  the  United  States, chronic  lead nephropathy  in
adults  was first noted among  illicit  whiskey consumers  in the  southeastern states.  The  pre-
revolutionary  tradition of homemade whiskey  ("moonshine")  was modernized during the Prohibi-
tion  era for large-scale production.   The  copper  condensers  traditionally used  in  the  illegal
stills  were replaced by truck  radiators  with  lead-soldered parts.   Illegally produced whiskey
might  contain  up to 74 mg of lead  per liter (Eskew et al.,  1961).   The enormous  variability in
moonshine  lead content has  recently  been reiterated in a study  of 12 samples from Georgia, of
which   five contained  less  than  10 ug/1 but one  contained 5.3  mg/1  (Gerhardt et  al.,  1980).
      Renal disease  often  accompanied  by  hypertension and gout was common  among  moonshiners
 (Eskew  et  al.,  1961;  Morgan et al. ,  1966;  Ball  and  Sorensen, 1969).   These patients  usually
 sought medical care because of symptomatic lead poisoning characterized  by colic,  neurological
 disturbances,  and  anemia,  although more  subtle  cases were  sometimes  detected by  use  of the
 i.v.  EDTA  lead-mobilization  test  (Morgan,  1968; Morgan and Burch, 1972).  While acute  sympto-
 matology,   including azotemia,  sometimes  improved during  chelation  therapy, residual  chronic
 renal   failure, gout, and hypertension frequently proved  refractory, thus indicating underlying
 chronic renal  disease superimposed on acute renal failure due to lead (Morgan, 1975).
 12.5.3.3   Occupational Lead Nephropathy.   Although  rarely  recognized   in  the United  States
 (Brieger  and   Rieders,  1959;  Anonymous,  1966;  Greenfield and  Gray, 1950;   Johnstone,  1964;
 Kazantzis,  1970;    Lane, 1949;   Malcolm,   1971; Mayers,  1947),  occupational lead  nephropathy,
 often  in  association  with  gout and hypertension, was widely  identified in  Europe  as a  sequela
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to overt  lead  intoxication  in the industrial setting  (Albahary  et al.,  1961,  1965;  Cramer et
al., 1974; Danilovic, 1958;  Galle and Morel-Maroger, 1965; Lejeune et al.,  1969;  Li Us  et al.,
1967, 1968;  Radosevic  et al., 1961;  Radulescu et  al. ,  1957;  Richet et al., 1964, 1966;  Tara
and Francon, 1975;  Vigdortchik,  1935).   Some of the more important recent studies are summa-
rized here.
     Richet et al.  (1964)  reported renal findings  in  eight  lead workers,  all  of whom  had re-
peated episodes of  lead poisoning, including colic.  Intravenous EDTA lead-mobilization tests
ranged from 587 to 5930 ug lead-chelate excretion per 24 hours.   Four of  these  men had  reduced
glomerular filtration  rates,  one had hypertension with gout, one  had hypertension alone, and
one had gout alone.   Proteinuria exceeded 200 mg/day in only one patient.   Electron microscopy
showed  intranuclear and  cytoplasmic inclusions  and ballooning  of mitochondria in proximal
tubule cells.  The  presence  of intranuclear inclusion bodies is helpful  in establishing a re-
lationship between  renal  lesions and lead toxicity, but  inclusion  bodies  are  not always pre-
sent  in  persons  with  chronic lead  nephropathy  (Cramer  et  al., 1974; Wedeen et al.,  1975,
1979).
     Richet et al.  (1966)  subsequently  recorded renal  findings  in 23 symptomatic lead  workers
in whom  blood  lead  levels  ranged from 30 to 87  ug/dl.   Six had diastolic pressures  over 90
mm Hg, three had  proteinuria exceeding  200 mg/day, and five had gout.  In  5 of 21 renal biop-
sies, glomeruli  showed minor  hyalinization,  but  two  cases  showed  major  glomerular disease.
Interstitial fibrosis  and arteriolar  sclerosis  were  seen  in all  but two biopsies.   Intra-
nuclear  inclusion bodies were noted in 13  cases.  Electron microscopy showed  loss of brush
borders,  iron-staining  intracellular  vacuoles,  and  ballooning of mitochondria in proximal
tubule epithelial  cells.
     Effective  renal  plasma  flow,  as  measured  by plasma  clearance of  para-aminohippurate
(C  . ),  was determined in 14 lead-poisoned Rumanian workers before and after chelation  therapy
by Lilis et al. (1967).  C  .  increased from a pre-treatment mean of 428  ml/min (significantly
less than  the  control  mean  of 580 ml/min) to  a  mean of 485 ml/min after chelation therapy (p
<0.02).   However, no significant increase  in glomerular filtration rate  (as determined by en-
dogenous  creatinine clearance)  was  found.   Lilis  et  al.  (1967)  interpreted the change in
effective  renal plasma  flow  as indicating reversal of  the  renal vasoconstriction that accom-
panied acute lead toxicity.   Although  neither blood lead concentrations  nor long-term  follow-
up observations of  renal  function were reported,  it  seems  likely  that most of these patients
suffered from acute, rather than chronic, lead nephropathy.
     In a  subsequent set of  102 cases of  occupational  lead poisoning studied  by Lilis et al.
(1968),  seven cases of clinically verified chronic nephropathy were found.   In  this group, en-
dogenous creatinine clearance was less  than 80 ml/min two weeks  or more after the last  episode
of lead  colic.  The mean blood  lead level  approximated 80 ug/dl  (range:  42-141 ug/dl.)  All
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patients excreted more  than  10 mg lead chelate  over  5 days during therapy consisting  of  2 g
CaNa2EDTA i.v. daily.   Nephropathy  was more common among  those  exposed  to lead for more than
10 years than  among  those exposed for  less  than 10 years.  Most of the  Rumanian lead workers
had experienced lead colic, and 13 of 17 had persistent hypertension that followed the appear-
ance of  renal  failure  by several years.  Proteinuria was absent except in two individuals  who
excreted 250 and 500 mg/1.  Hyperuricemia was not evident in the absence  of azotemia.   In both
studies  by  Lilis  et al.  (1967,  1968),  reduced  urea clearance preceded  reduced  creatinine
clearance.
     Cramer et al.  (1974) examined  renal  biopsies from five lead  workers  exposed  for 0.5-20
years in Sweden.   Their blood  lead levels ranged from  71 to 138 (jg/dl, with glomerular filtra-
tion rates  ranging from  65  to  128  ml/min, but  C  .  exceeding 600 ml/min in  all.   Although
plasma concentrations of  valine, tyrosine, and phenylalanine were  reduced, excretion of these
amino acids  was  not  significantly different from  controls.  A  proximal  tubular reabsorptive
defect might,  therefore,  have been present without increased amino acid excretion because of
low circulating  levels:   increased  fractional excretion may have  occurred without increased
absolute  amino  acid  excretion.   Albuminuria and glycosuria were not present.  Glomeruli were
normal by electron  microscopy.  Intranuclear inclusions in proximal tubules were found in two
patients  with  normal   GFRs,   and  peri tubular  fibrosis was  present  in  the  remaining three
patients who had had the  longest occupational exposure (4-20 years).
     Wedeen  et al.   (1975,  1979) reported on renal  dysfunction  in  140 occupationally  exposed
men.  These  investigators used  the EDTA  lead-mobilization test (1 g CaNa2EDTA  with 1 ml of
2 percent procaine given  i.m.  twice, 8-12  hr apart) to detect workers with excessive body  lead
stores.   In  contrast to  workers with  concurrent lead exposure  (Alessio  et al., 1979), blood
lead  measures have proven unsatisfactory  for detection of past  lead  exposure  (Baker et  al. ,
1979; Havelda  et al.,  1980; Vitale  et al. , 1975).  Of  the 140  workers  tested, 113  excreted
1000  [jg or more of lead-chelate  in 24  hr compared with a normal  upper limit of 650 pg/day
(Albahary  et  al., 1961;  Emmerson,  1973;  Wedeen et  al.,  1975).   Glomerular filtration rates
(GFR)  measured by  125I-iothalamate  clearance  in  57  men  with  increased mobilizable lead  re-
vealed  reduced renal  function in  21 (GFR  less than 90  ml/min per  1.73 m2  body surface area).
When workers  over age 55  or with gout,  hypertension,  or other possible causes of  renal  disease
were excluded, 15 remained who had previously  unsuspected  lead nephropathy.   Their  GFRs ranged
between  52 and  88  ml/min per 1.73  m2.   Only three of  the men  with occult renal  failure had
ever  experienced  symptoms  attributable  to  lead  poisoning.   Of the  15  lead  nephropathy
patients, one  had a  blood lead level over  80 M9/dl, three  repeatedly had  blood  levels under 40
pg/dl,  and  eleven had  blood  levels  between 40  and 80 (jg/dl  at the time  of  the study. Thus,
blood  lead levels  were poorly  correlated with  degree of renal dysfunction.  The  failure of

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blood  lead  level  to predict the presence of lead nephropathy probably stems from the indepen-
dence  of  blood  lead from cumulative bone  lead  stores  (Gross,  1981; Saenger et al.,  1982a,b).
     Percutaneous renal  biopsies  from  12 of the lead workers with reduced GFRs revealed focal
interstitial nephritis in six.   Non-specific changes were present in proximal  tubules,  includ-
ing  loss of brush borders,  deformed mitochondria, and  increased  lysosomal   bodies.   Intra-
nuclear inclusion bodies  were  not found in the  renal  biopsies  from these men who had  experi-
enced  long-term occupational exposure  and  who had  had  chelation  tests  shortly before  biopsy.
In  experimental  animals, chelation  results  in  the rapid disapperance of  lead-induced intra-
nuclear inclusions  (Goyer and  Wilson,  1975).   The  detection  of a  variety of iimnunoglobulirt
deposits  by fluorescent microscopy  suggests  (but  does  not prove)  the possibility  that  some
stages of lead nephropathy in adults may be mediated by immune  mechanisms.
     Eight  patients with  pre-azotemic  occupational  lead  nephropathy were  treated with  1 g
CaNa2EDTA (with procaine) i.m.  three times  weekly for 6-50 months.   In four patients, GFR  rose
by  20  percent  or  more by the time  the  EDTA test had fallen to  less than 850 ug Pb/day.   The
rise  in  GFR was  paralleled  by increases  in  effective  renal  plasma flow (C  .)  during  EDTA
treatment.  These findings  indicate that chronic lead nephropathy may be  reversible  by chela-
tion  therapy,  at  least  during  the pre-azotemic  phase  of the  disease (Wedeen et  al.,  1979).
However,  much  more  information  will have  to be  obtained on the value of  long-term,  low-dose
chelation therapy  before this  regimen  can be  widely  recommended.   There is, at  present,  no
evidence  that  interstitial  nephritis  itself is  reversed by chelation therapy.   It may  well  be
that only functional  derangements  are  corrected and that the improvement  in GFR is not accom-
panied by disappearance  of  tubulo-interstitial  changes in  kidney.   Chronic volume depletion,
for example, might  be  caused by lead-induced  depression of the  renin-angiotension-aldosterone
system  (McAllister  et al.,  1971)  or by direct  inhibition  of (Na+,  K+)ATPase-mediated sodium
transport (Nechay and  Williams, 1977;  Nechay  and Saunders,  1978a,b,c; Raghavan  et al., 1981;
Secchi et al.,  1973).   On the  other hand, volume  depletion would be expected to produce  pre-
renal  azotemia, but this was not evident in these patients.   The value of  chelation therapy in
chronic lead nephropathy once azotemia  is established is unknown.
     The prevalence of  azotemia among  lead workers has recently been confirmed in health  sur-
veys conducted  at industrial sites  (Baker et al.,  1979;  Hammond et al., 1980;  Landrigan  et
al., 1982;  Lilis  et al.,  1979,  1980).    Interpretation  of  these  data is,  however,  hampered by
the weak correlation generally  found between blood lead levels  and chronic lead nephropathy in
adults, the absence of matched  prospective controls, and the lack  of detailed diagnostic in-
formation  on the workers found  to  have  renal  dysfunction.   Moreover, blood serum urea nitrogen
(BUN)  is a relatively poor indicator of renal  function  because  it is sensitive to a variety of
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physiological variables  other than  GFR,  including protein anabolism, catabolism,  and  hydra-
tion.  Several other  measures of renal function are more  reliable than  the BUN,  including in
order of  increasing clinical  reliability:   serum creatinine,  endogenous  creatinine clearance,
and  125I-iothalamate  or  inulin clearance.   It should be noted  that none of these measures of
GFR  can be   considered reliable in the  presence of any acute  illness such as lead  colic or
encephalopathy.   Elevated  BUN in field surveys may, therefore,  sometimes  represent transient
acute functional changes rather than chronic intrinsic renal disease.
     The  variable  susceptibility of the  kidneys  to the nephrotoxic effects  of  lead suggests
that  environmental  factors in addition to  lead  may participate  in  the  expression  of renal
damage.   Industrial workers  are often exposed to a variety of toxic materials, some of which,
such  as  cadmium (Buchet et  al.,  1980), are themselves nephrotoxic.   In  contrast to cadmium,
lead  does  not  increase  urinary excretion  of beta-2-microglobulins  (Batuman et  al., 1981;
Buchet et al.,  1980)  or lysozyme (Wedeen et al., 1979) independently of increased low-molecu-
lar-weight  proteinuria induced  by  renal  failure  itself.   Multiple interactions  between en-
vironmental  toxins may  enhance  susceptibility  to  lead  nephrotoxicity.   Similarly,  nephro-
toxicity  may be modulated by  reductions in 1,25-dihydroxyvitamin  D3, increased 6-betahydroxy-
cortisol   production   (Saenger   et   al.,   1981,  1982a,b),   or   immunologic   alterations
(Gudbrandsson  et  al.,  1981;  Koller   and  Brauner,  1977; Kristensen,  1978;  Kristensen and
Andersen,  1978).   Reductions  in  dietary intake of  calcium,  copper,  or  iron similarly  appear to
increase  susceptibility  to lead  intoxication (Mahaffey  and  Michael son, 1980).
      The  slowly progressive chronic lead nephropathy  resulting from years of relatively  low-
dose lead absorption  (i.e.,  insufficient to produce symptoms of  acute  intoxication) observed
in adults is strikingly different  from the  acute  lead  nephropathy arising from the  relatively
brief but intense  exposure arising  from childhood  pica.  Typical  acid-fast intranuclear inclu-
sions are, for example, far  less common  in  the  kidneys of adults (Cramer  et  al.,  1974; Wedeen
et al.,  1975).   Although  aminoaciduria has  been  found  to  be  greater  in  groups of lead  workers
than in  controls  (Clarkson and  Kench, 1956; Goyer et  al.,  1972), proximal tubular dysfunction
is more  difficult to  demonstrate in adults with  chronic  lead  nephropathy than  in acutely ex-
posed children  (Cramer  et al., 1974).  It  should be  remembered, however, that  children  with
the Fanconi syndrome  have  far more severe acute  lead intoxication than is  usual  for workmen on
the job.    In contrast to  the reversible  Fanconi  syndrome  associated  with childhood lead poi-
soning,  proximal  tubular  reabsorptive defects  in occupationally exposed  adults  are uncommon
and subtle; clearance measurements are often required to discern impaired tubular reabsorption
 in chronic  lead nephropathy.   Hyperuricemia is  frequent among  lead workers  (Albahary et al.,
 1965; Garrod,  1859;  Hong  et  al.,  1980;  Landrigan et  al., 1982),  presumably  a  consequence of
 specific lead inhibition  of  uric acid excretion,  increased  uric acid production (Emmerson et

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al., 1971;  Granick  et al.,  1978; Ludwig, 1957), and pre-renal azotemia from volume depletion.
The hyperuricemia in adults contrasts with the reduced serum uric acid levels usually associa-
ted with  the  Fanconi  syndrome in childhood lead poisoning.   Although aminoaciduria and  glyco-
suria are  unusual  in  chronic lead nephropathy, Hong et al.  (1980) reported a disproportionate
reduction in the maximum reabsorptive rate for glucose compared with para-aminohippurate (PAH)
in  five  of six  lead  workers they  studied.   PAH transport has not  been  consistently altered
beyond that expected  in  renal  failure  of  any etiology  (Hong  et al.,  1980;  Wedeen et  al.
1975).   Biagini  et  al.  (1977) have, however,  reported  a  good negative linear correlation be-
tween the one-day EDTA lead-mobilization test and C  .  in 11 patients with histologic evidence
of lead-induced ultrastructural  abnormalities in proximal  tubules.
     The differences  between  lead nephropathy in children and adults would not appear to be a
consequence of the route of exposure, since a case of pica in an adult (geophagic  lead nephro-
pathy) studied by Wedeen et al.  (1978) showed the characteristics of chronic rather than acute
lead nephropathy.  Intranuclear inclusions were absent, and the GFR was reduced out of propor-
tion to the effective  renal  plasma flow.
12.5.3.4   Lead and Gouty Nephropathy.   Renal  disease  in gout can often be attributed to well-
defined pathogenetic mechanisms  including urinary tract stones and acute hyperuricemic nephro-
pathy with  intratubular uric acid  deposition  (Bluestone  et al.,  1977).   In the  absence of
intra- or extra-renal  urinary tract obstruction, the frequency,  mechanism, and even the  exist-
ence of a  renal  disease peculiar to gout  remains  in  question.   While some investigators have
described "specific"  uric acid-induced  histopathologic changes in both glomeruli  and tubules
(Gonick et  al.,  1965;  Sommers and  Churg,  1982), rigorously  defined  controls  with comparable
degrees of  renal  failure  were not studied simultaneously.   Specific histologic changes  in the
kidneys in  gout  have  not  been found by  others (Pardo  et al. , 1968;  Bluestone  et  al.,  1977).
Glomerulonephritis,  vaguely  defined  "pyelonephritis"  (Heptinstall,  1974),  or  intra-  and
extra-renal obstruction may  have  sometimes been confused with  the  gouty  kidney,  particularly
in earlier  studies  (Fineberg  and Altschul, 1956; Gibson  et  al. ,  1980b; Mayne, 1955; McQueen,
1951; Schnitker and Richter, 1936; Talbott and Terplan, 1960; Williamson,  1920).
     The histopathology of  interstitial  nephritis  in gout appears to be non-specific and can-
not  usually be  differentiated from that of pyelonephritis,  nephrosclerosis,  or  lead nephro-
pathy on morphologic grounds alone (Barlow and Beilin,  1968;  Bluestone et al., 1977; Greenbaum
et  al. ,  1961;  Heptinstall,  1974; Inglis et  al. ,  1978).  Indeed, renal histologic  changes in
non-gouty  hypertensive  patients  have been  reported to  be  identical  to  those found in gout
patients (Cannon et al., 1966).   In these hypertensive patients, serum uric acid levels  paral-
leled the BUN.
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     Confusion between glomerular  and  interstitial  nephritis can in part  be  explained by the
tendency of proteinuria to  increase as renal failure progresses, regardless of the underlying
etiology (Batuman et al.,  1981).   In the absence of overt lead intoxication it may, therefore,
be  difficult  to recognize  surreptitious lead  absorption  as a  factor contributing to  renal
failure in gouty patients.   Further, medullary urate deposits, formerly believed to be  charac-
teristic of gout  (Brown  and Mallory, 1950; Mayne, 1955; McQueen, 1951; Fineberg and Altschul,
1956; Talbott and  Terplan,  I960),  have more recently been reported in end-stage renal  disease
patients with no  history  of gout  (Cannon  et al.,  1966; Inglis et al.,  1978;  Linnane  et al.,
1981; Ostberg,  1968;  Verger et al., 1967).   Whether such  crystalline deposits contribute to,
or  are  a  consequence of,  renal damage  cannot be determined with confidence.   In the presence
of  severe  hyperuricemia  (serum uric acid greater than 20 (jg/dl), intraluminal crystal  deposi-
tion  may  produce  acute  renal  failure  because of tubular  obstruction  associated with  grossly
visible medullary  streaks  (Emmerson, 1980).  In chronic renal failure without gout or massive
hyperuricemia,  the functional  significance of such  medullary deposits is  unclear (Linnane et
al.,  1981).   Moreover, medullary  microtophi, presumably  developing  around intraluminal depo-
sits, may  extend into the  renal interstitium,  inducing foreign body reactions with giant cell
formation.  Such deposits are  sometimes  overlooked  in routine histologic preparations, as they
may be  dissolved in  aqueous fixatives.   Their histologic identification  requires alcohol fixa-
tion  and  deGalantha  staining  (Verger  et  al. ,  1967).  Because  of  the acid milieu, medullary
deposits  are  usually  uric  acid,  while  microtophi  developing in the  neutral  pH of the renal
cortex  are usually monosodium  urate.   Both  amorphous and needle-like  crystals  have been  demon-
strated in kidneys of non-gout  and hyperuricemic patients,  frequently in  association  with ar-
teriolonephrosclerosis (Inglis et  al.,  1978;  Cannon et  al.,  1966; Ostberg,  1968).  Urate depo-
sits, therefore, are not only  not  diagnostic, but may be the result,  rather than the cause, of
interstitial  nephritis.  The problem of identifying unique characteristics of  the  gouty  kidney
has been  further  confounded by the coexistence  of pyelonephritis, diabetes mellitis, hyperten-
sion, and  the aging  process itself.
      Although the outlook  for gout patients with  renal  disease was  formerly  considered  grim
(Talbott,  1949; Talbott and Terplan,  1960), more  recent  long-term  follow-up  studies suggest  a
benign  course  in  the absence of  renovascular  or  other supervening disease (Fessel,  1979; Yu
and Berger,  1982;  Yu,  1982).  Over  the  past  four decades the reported incidence  of renal
disease in gout patients  has  varied from greater than 25  percent (Fineberg and Altschul, 1956;
Hench et  al., 1941;  Talbott,  1949; Talbott and Terplan, 1960; Wyngaarden,  1958) to less than  2
percent,  as observed  by Yu (1982) in 707  patients followed from 1970 to  1980.  The  low inci-
dence of renal disease  in  some  hyperuricemic populations  does  not  support the view that ele-
vated serum uric acid levels of the degree ordinarily encountered in gout patients are harmful
 to the kidneys (Emmerson,  1980;  Fessel,  1979;  Ramsay, 1979; Reif et al. , 1981).  Similarly,
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the  failure  of the  xanthine oxidase  inhibitor,  allopurinol,  to reverse the course  of  renal
failure in gout patients despite marked reductions in the serum uric acid (Bowie et al.,  1967;
Levin and Abrahams, 1966; Ogryzlo et al., 1966; Rosenfeld, 1974; Wilson et al.,  1967)  suggests
that renal disease  in gout may be due in part to factors other than uric acid.   Some studies
have,  however,  suggested a  possible slowing  of  the  rate of progression of renal  failure  in
gout by allopurinol  (Gibson  et al.,  1978, 1980a,b; Briney et al.,  1975).   While the contribu-
tion of uric  acid to the renal disease  of gout remains controversial, the hypothesized  dele-
terious effect  of hyperuricemia on  the kidney has no bearing on other potential  mechanisms  of
renal damage in these patients.
     Although hyperuricemia  is  universal  in patients with renal failure,  gout  is rare in such
patients except when  the renal failure is  due  to lead.   Gout occurs in approximately half  of
the patients with lead  nephropathy  (Emmerson, 1963, 1973; Ball  and Sorensen,  1969; Richet  et
al., 1965).  Moreover, among gout patients in Scotland without known lead exposure, blood lead
levels were found to  be higher than in  non-gouty controls (Campbell et al. , 1978).   The long
association of  lead  poisoning  with  gout raises the possibility that lead absorption  insuffi-
cient to produce overt lead intoxication may, nevertheless, cause gout with slowly progressive
renal  failure.   Garrod  (1859), Ball  and  Sorensen (1969), and Emmerson et al.,  (1971) demon-
strated that lead reduces  uric acid excretion, thereby  creating the internal  milieu  in  which
gout can be expected.   The mechanism of hyperuricemia in lead poisoning is,  however,  unclear.
Serum  uric  acid  levels would  be  expected to rise in association with lead-induced pre-renal
azotemia;  increased proximal tubule  reabsorption  of uric  acid  could result  from reduced glo-
merular filtration  rate due to chronic volume depletion.   Increased  tubular  reabsorption  of
uric  acid  in   lead  nephropathy  has  been  suggested  by  the  pyrazinamide  suppression  test
(Emmerson  et  al.,  1971),  but  interpretation  of this  procedure was questioned  (Holmes  and
Kelley, 1974).  Lead-induced inhibition  of tubular secretion of uric acid,  therefore, remains
another possible  mechanism of  reduced uric acid  excretion.   In addition,  some  investigators
have  found increased  uric  acid  excretion  in saturnine  gout  patients,  thereby  raising  the
possibility  that  lead   increases  uric  acid  production in  addition to  reducing uric  acid
excretion (Emmerson et al., 1971;  Ludwig, 1957; Granick et al.,  1978).
     To  test   the hypothesis  that   undetected  lead absorption may  sometimes  contribute  to
renal failure  in  gout,  Batuman et al.  (1981)  administered the  EDTA lead-mobilization test  to
44 armed service  veterans  with gout  and assessed  their renal function.  Individuals currently
exposed to lead (e.g., lead workers)  were excluded.   Collection of  urine during the EDTA  lead-
mobilization test was extended to three days because reduced GFR delays excretion of  the lead
chelate (Emmerson, 1963).  Note that the EDTA test does not  appear  to be nephrotoxic  even for
patients with preexisting  renal  failure (Wedeen et al., 1983).   Half of the gout patients had
normal  renal  function and  half had  renal  failure as  indicated by  serum  creatinines  over 1.5
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mg/dl (mean =  3.0;  standard  error =0.4 mg/dl), reflecting approximately 70 percent reduction
in renal function.  The groups were comparable with regard to age, duration of gout, incidence
of hypertension,  and  history of past lead exposure.  The mean (and standard error) blood lead
concentration  was 26 (± 3) jjg/dl  in the  patients with  reduced  renal  function  and  24 (± 3)
ug/dl in the gout patients with normal kidney function.  The gout patients with renal  dysfunc-
tion, however,  excreted  significantly more lead chelate than did those without renal  dysfunc-
tion  (806  ± 90 versus 470 ±  52 ug  lead over  3 days).   Ten control  patients with comparable
renal failure  excreted  424 ± 72 jjg lead during  the  3-day EDTA test (2 g i.m.).  The non-gout
control  patients  with renal  failure had  normal  lead stores  (Emmerson,  1973;  Wedeen et al.,
1975),  indicating that  the excessive mobilizable  lead in the gout patients with renal failure
was  not a  consequence of reduced renal function per se.  The source of lead  exposure in these
armed service  veterans  could not be  determined with confidence.  A history of transient occu-
pational exposure and occasional moonshine consumption was common among  all  the veterans, but
the  medical  histories did  not correlate  with either the  EDTA  lead-mobilization test or the
presence of  renal failure.   The  relative  contributions  of airborne lead,  industrial sources,
and  illicit whiskey to the  excessive body lead  stores demonstrated by the  EDTA lead-mobiliza-
tion test  could not,  therefore, be  determined.
     These studies  suggest that excessive  lead  absorption may  sometimes be  responsible for the
gouty  kidney  in contemporary patients, as appeared  to be the  case  in the past  (Wedeen, 1981).
Although  the   EDTA  lead-mobilization test cannot  prove  the  absence  of  other  forms  of renal
disease,  a positive  EDTA test  can  indicate that lead may  be  a contributing cause of renal
failure when other  known  causes  are excluded  by appropriate diagnostic  studies.
12.5.3.5   Lead and Hypertensive Nephrosclerosis.   Hypertension  '* another putative  complica-
tion of excessive  lead absorption  that  has a  long  and controversial  history.  In  the older
literature hypertension was  often linked to lead  poisoning,  frequently  in association with
renal  failure  (Beevers et al. ,  1980; Dingwall-Fordyce and Lane,  1963;  Emmerson,  1963;  Legge,
1901;  Lorimer, 1886; Morgan,  1976;  Oliver,  1891;  Richet et al.,  1966;  Vigdortchik, 1935); but
a number  of   other  investigators  also failed  to  find such an association (Belknap, 1936;
Brieger and Rieders,  1959;   Cramer  and Dahlberg,  1966;  Fouts and Page, 1942; Malcolm, 1971;
Mayers, 1947;  Ramirez-Cervantes et al., 1978).   Much more consistent  evidence for associations
between lead  exposure and hypertension has  emerged, however,  from numerous recent studies  (as
discussed  in  the  1986  Addendum  to  this document).   This includes  epidemiological  evidence
which suggests that  hypertension  is  possibly mediated by lead-induced  renal  effects.  Some  of
the evidence pointing toward renal involvement is concisely reviewed  below.
      Among non-occupationally  exposed individuals  in  Scotland,  hypertension  and serum  uric
acid levels have been  found to correlate with  blood  lead levels (Beevers et al., 1976).   The

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kidneys  of  patients with  chronic  lead nephropathy  may  show uric acid deposits and the  vas-
cular changes  of  "benign  essential  hypertension" even in the absence of gout and  hypertension
(Cramer et al., 1974; Inglis et al., 1978; Morgan, 1976;  Wedeen et al.,  1975).   In a  long-term
follow-up study  of 624 patients  with gout,  Yii  and  Berger (1982) reported  that while  hyper-
uricemia alone had  no  deleterious  effect on renal function,  decreased renal  function was  more
likely to occur in gout patients with hypertension and/or ischemic heart disease than in those
with uncomplicated gout.
     Hypertension by itself is widely accepted as a cause of  renal failure,  although  the renal
sequelae of  moderate hypertension  appear  to be less  dramatic than in the past (Kincaid-Smith
1982).    In  order to determine  if unsuspected excessive  body lead stores might contribute  to
the renal disease of hypertension,  3-day EDTA (2  g i.m.)  lead-mobilization tests were perform-
ed  in  hypertensive armed  service  veterans with  and without  renal  failure  (Batuman et  al.
1983).    A  significant  increase  in  mobilizable  lead  was found in hypertensive subjects  with
renal disease  compared to those without  renal  disease.   Control  patients with renal failure
again  demonstrated  normal mobilizable   lead,  thereby   supporting  the view that  renal fail-
ure is not responsible  for the excess mobilizable lead in patients with  hypertension  and renal
failure.   These findings  suggest that patients who would  otherwise be deemed  to  have  essential
hypertension with nephrosclerosis can be shown to have underlying  lead nephropathy by the  EDTA
lead-mobilization test  when other renal causes of hypertension are excluded.
     The mechanism whereby lead induces hypertension  remains  unclear.  Although  renal disease
particularly at the  end-stage,  is  a recognized cause of  hypertension,  renal  arteriolar  histo-
logic changes may precede  both hypertension and renal disease (Wedeen et al., 1975).  Lead may
therefore induce  hypertension  by direct  or indirect effects  on the  vascular system  (see  Sec-
tion 12.9.1 and the Addendum to this document).
     Studies of hypertension  in moonshine consumers  have indicated the  presence of hyporenin-
emic hypoaldosteronism.  A blunted  plasma renin  response to  salt  depletion  has  been  described
in  lead  poisoned  patients;  this  response can  be  restored to  normal  by  chelation therapy
(McAllister  et al.,  1971; Gonzalez  et al.,  1978;  Sandstead et al., 1970a).   The diminished
renin-aldosterone responsiveness found in  moonshine  drinkers could  not,  however, be  demon-
strated  in  occupationally exposed men with acute lead  intoxication (Campbell  et  al.,  1979).
Although the  impairment  of the renin-aldosterone system  appears  to be  independent of renal
failure and  hypertension,  hyporeninemic hypoaldosteronism due to  lead might  contribute  to the
hyperkalemia (Morgan, 1976) and the exaggerated  natriuresis   (Fleischer et al., 1980) of  some
patients with  "benign  essential  hypertension."   Since urinary kallikrein excretion is reduced
in lead workers with hypertension,  it has  been suggested  that the  decrease in this  vasodilator
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may contribute to lead-induced hypertension (Boscolo et al., 1981).   The specificity of kalli-
krein suppression in the renal and hypertensive manifestions of excessive lead absorption can-
not,  however, be   determined  from  available  data,  because   lead   workers  without hyper-
tension  and  essential hypertensive  patients  without undue lead absorption  also  have reduced
urinary  kallikrein excretion.
12.5.3.6  General Population  Studies.   Few studies have been performed to evaluate the possi-
ble harmful effects of lead on the kidneys in populations without suspected excessive lead ab-
sorption from occupational or moonshine exposure.
     An  epidemiological survey in Scotland of households with water lead concentrations in ex-
cess of  WHO recommendations  (100 M9/1)  revealed a  close correlation between water lead content
and blood  lead and serum urea concentrations (Campbell et al., 1977).  In 970 households lead
concentrations  in  drinking  water ranged from <0.1 to >8.0 mg/1.  After clinical and  biochemi-
cal screening of 283  subjects from 136  of  the households with water lead concentrations in ex-
cess of  100 ug/1, a subsample of 57  persons with normal blood pressure and elevated serum urea
(40  ug/dl)  was  compared  with a control group  of  54 persons drawn from  the study group with
normal  blood pressure and  normal  serum urea.  The  frequency  of renal dysfunction in indivi-
duals with  elevated blood lead concentratons  (>41 ug/dl)  was  significantly  greater  than that
of age-  and  sex-matched controls.
     Since  62  general practitioners took  part  in  the screening, the  subsamples may  have come
from many different areas;  however,  it  was not  indicated  if matching  was done for place of re-
sidence.   The authors  found a significantly larger number of high blood lead concentrations
among  the  persons with elevated serum  urea and claimed that elevated water  lead concentration
was  associated  with  renal  insufficiency  as  reflected by raised  serum urea  concentrations.
This  conclusion is difficult to accept since serum urea  is not the  method  of choice for eva-
luating  renal function.   Despite  reservations concerning  use  of the BUN for  assessing  renal
function (due  to transient  fluctuations),  these findings  are consistent with the  view that ex-
cessive  lead absorption from household water causes renal dysfunction.  However,  the authors
used  unusual statistical methods  and  could not exclude the reverse causal  relationship,  i.e.,
that  renal  failure had  caused  elevated blood  lead  levels in  their study group.   A  carefully
matched  control  population  of azotemic individuals from low  lead households would  have  been
 helpful  for this purpose.   A more convincing  finding  in  another subsample was a strong asso-
ciation  between hyperuricemia  and blood lead  level.   This was also interpreted as  a sign  of
 renal  insufficiency,  but it may  have represented a direct effect of lead on uric acid produc-
 tion or  renal  excretion.
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     Campbell et al.  (1977)  also found a statistically  significant  correlation  between blood
lead concentration  and hypertension.   Tap-water  lead did not, however, correlate with  blood
lead among  the  hypertensive group,  thus  suggesting  that other environmental sources of  lead
may account  for the  presence of high blood  lead  concentrations  among hypertensive persons  in
Scotland (Beevers  et al.,  1976, 1980).

12.5.4  Mortality  Data
     Cooper  and Gaffey  (1975)  analyzed  mortality data available  from  1267  death certificates
for 7032  lead workers  who  had been hired by  16  smelting or battery plants between  1900 and
1969.   Standardized mortality ratios revealed an excess of observed over predicted deaths  from
"other hypertensive  disease" and "chronic nephritis  and  other renal  sclerosis."  The authors
concluded that "high levels of lead absorption such as occurred in many of  the workers in this
series, can  be  associated with  chronic  renal  disease."  In  an  extension of this  mortality
study  covering  the period 1971-1975 (Cooper,  1981),  the excess  of deaths  from  "other  hyper-
tensive disease"  and  "chronic  nephritis"  was no  longer evident.   In the follow-up  study,
deaths from  major  cardiovascular and renal  diseases  were "slightly higher  than  expected," but
did not reach statistical  significance (Cooper, 1981).  Cooper (1984) recently reexamined data
for a  more  rigorously selected subset of the same population (6819 workers versus 7032  origi-
nally) for the  period 1947-1980.   He found  significantly  greater than expected  mortality for
both battery plant and lead smelter workers.   These excess deaths appeared  to result  primarily
from  malignant  neoplasms  (but  not renal  malignancies), chronic  renal  disease,  and  "ill-
defined" causes.   Chronic  renal  disease reflected two general classifications:   "other  hyper-
tensive disease" and "chronic and unspecified nephritis."  Most of these deaths  occurred prior
to 1971, which accounts for the lack of such findings in Cooper's (1981) analysis of  1971-1975
data.   Cooper (1984)  noted  that, although battery plant workers  showed the greatest  excess  of
deaths  from  these  causes,  they  did not show  significantly elevated  standardized  mortality
ratios for hypertensive heart  disease  or stroke.   Despite the lack of excess of renal  carci-
noma in Cooper's analyses,  kidney tumors have been found in lead-poisoned experimental animals
(see Section 12.7) and  in  at least two cases of occupationally exposed workers  (Baker et al.,
1980;  Lilis,  1981).  Selevan et al.  (1984) have also  noted an increased, but not  statistically
significant,  incidence of  renal cancer in a  group of  lead smelter workers.
     In a more  limited study of 241 Australian  smelter employees who were diagnosed as  lead
poisoned between 1928  and  1959 by a government medical  board,  140 deaths  were  identified be-
tween  1930 and  1977  (McMichael  and Johnson, 1982).   Standard proportional  mortality rates  of
the lead-exposed  workers   compared  with  695 non-lead-exposed employees revealed an overall
threefold  excess  in  deaths  due  to  chronic  nephritis and a twofold excess in  deaths  due  to
cerebral  hemorrhage  in the  lead-exposed workers.   Over the 47  years of  this  retrospective
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study, the number of  deaths  from chronic nephritis decreased from an initial  level  of 36  per-
cent to 4.6 percent  among  the lead-exposed workers, compared  with a drop from 8.7  percent to
2.2  percent  among  controls.   From  1965  to  1977 the  age-standard!'zed  mortality  rates  from
chronic nephritis were the same for  the  lead-worker and control  groups,  although  both  rates
were  higher  than the  proportional  mortality  rate for the  general  population of  Australian
males.  The  latter  observation  indicated  that  the excessive  deaths from chronic nephritis
among lead-poisoned workers at the smelter had declined in recent decades.
     Despite substantial evidence that lead produces interstitial nephritis in adults, the im-
pact  of chronic  lead nephropathy on the general  population is unknown.   The diagnosis of lead
nephropathy is  rarely  made  in dialysis patients  in the  United States.  The  absence of the
diagnosis does not,  however,  provide evidence for the absence of the disease.  Advanced renal
failure is usually encountered only many years after excessive lead exposure.   Moreover, acute
intoxication may never  have occurred, and neither  heme enzyme abnormalities nor elevated blood
lead  levels may  be  present at the  time  renal  failure becomes apparent.   The causal relation-
ship  between  lead absorption  and renal  disease may therefore  not  be evident.   It is likely
that  such cases  of  lead  nephropathy  have previously  been included among  other  diagnostic
categories such as pyelonephritis, interstitial  nephritis, gouty nephropathy, and hypertensive
nephrosclerosis.   Increasing  proteinuria  as  lead nephropathy  progresses may also  cause con-
fusion  with  primary  glomerulonephritis.   It  should  also be  noted  that  the  End  Stage Renal
Disease  Program  (U.S.  Health  Care Financing Administration,  1982)  does not  even  include the
diagnosis  of  lead  nephropathy in  its  reporting  statistics,  regardless of whether the diag-
nosis is  recognized  by the attending  nephrologist.

12.5.5  Experimental  Animal Studies  of the Pathophysiology of  Lead Nephropathy
      Laboratory  studies of experimental  animals  have helped clarify  a number  of the mechanisms
underlying  lead-induced nephropathy  in  humans.    The  following discussion will center on the
renal uptake  and intracellular  binding  of lead, morphological  alterations, various functional
changes,  and  biochemical effects associated with the renal toxicity of  lead.
12.5.5.1   Lead Uptake by the Kidney.   Lead uptake by  the kidney  has been  studied  in vivo and
 in vitro  using slices of renal tissue.   Vander et al.  (1977) performed  renal  clearance studies
 in dogs two hours  after a single i.v.  dose  of  0.1 or 0.5  mg  lead  acetate containing 1-3 mCi
of 203Pb or 1 hour  after  continous i.v.  infusion of 0.1-0.15 mg/kg-hour.  These  investigators
 reported  that 43-44 percent of the  plasma lead was ultrafiltrable, with kidney reabsorption
 values of 89-94 percent for  the ultrafiltrable  fraction.  A subsequent stop-flow analysis in-
 vestigation by Victery et al.  (1979a),  using dogs given a single i.v.  dose of lead acetate at
 0.2 or 10.0 mg/kg,  showed both proximal and distal  tubular reabsorption sites for lead.   Dis-
 tal  reabsorption was  not linked  to  sodium chloride or  calcium transport pathways.   Proximal
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tubule  reabsorption  was  demonstrated  in  all  animals  tested  during citrate or  bicarbonate
infusion.  Another  experiment by Victery  et  al.  (1979b) examined the  influence of  acid-base
status on  renal  accumulation  and excretion of  lead  in  dogs given 0.5-50 ug/kg hour  as an in-
fusion or in rats given access to drinking water containing 500 ppm lead for 2-3  months.   They
showed that alkalosis  increased  lead entry into tubule cells via both luminal  and  basolateral
membranes, with  a  resultant  increase in both renal  tissue  accumulation and urinary  excretion
of  lead.   Similarly,  acutely  induced alkalosis increased  lead excretion  in  rats previously
exposed through  their  drinking water.  The authors  concluded  that  earlier  results from acute
exposure experiments on  the  renal  handling of lead (Vander et al.,  1977) were at least quali-
tatively similar to results  of the chronic exposure experiments and that rats were an accept-
able  model  for  investigating the  effects of  alkalosis  on the  excretion  of lead  following
chronic exposure.
     Itn vitro studies  (Vander et  al., 1979) using slices of rabbit kidney incubated with 203Pb
acetate at lead  concentrations of  0.1 or  1.0 pM  over 180-minute time intervals  showed that a
steady-state uptake of 203Pb by slices (ratio of slice to medium uptake in the range  of 10-42)
was reached after 90 minutes and  that lead could enter the slices as a free  ion.   Tissue slice
uptake was  reduced by a number  of  metabolic inhibitors,  thus suggesting  a  possible active
transport mechanism.   Tin (Sn IV)  markedly reduced  203Pb  uptake into the  slices but  did not
affect lead efflux  or  para-aminohippurate accumulation.  This  finding  raises  the  possibility
that Pb and Sn (IV) compete for a common carrier.   Subsequent studies also using  rabbit kidney
slices (Vander  and Johnson,  1981)  showed that co-transport of 203Pb into the  slices  in the
presence of organic anions  such  as cysteine,  citrate, glutathione,  histidine, or serum ultra-
filtrate was relatively small  compared with uptake due to ionic lead.
     In summary, it is  clear  from the above iji  vivo and HI vitro studies on several  different
animal species  that renal accumulation of lead  is  an  efficient process that occurs  in both
proximal  and  distal  portions  of the nephron and  at both  luminal  and  basolateral membranes.
The transmembrane movement of lead appears to be mediated by an uptake process that is subject
to inhibition by several  metabolic  inhibitors and the acid-base status of the organism.
12.5.5.2   Intracellular  Binding  of Lead in the  Kidney.   The bioavailability  of lead  inside
renal tubule cells  under low  or  203Pb-tracer exposure conditions is mediated in  part by bind-
ing  to  several  high-affinity  cytosolic  binding proteins (Oskarsson  et  al.  ,  1982; Mistry et
al.,  1982)  and,  at higher  exposure  conditions,  by the  formation  of cytoplasmic and intra-
nuclear  inclusion  bodies (Goyer et  al.,  1970a).   These inclusion bodies  have  been  shown by
both cell fractionation (Goyer et al., 1970a) and X-ray microanalysis (Fowler et  al.,  1980) to
contain  the  highest intracellular concentrations  of lead.   Saturation  analysis of  the renal
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63,000 dalton (63K) cytosolic  binding  protein has  shown  that  it  possesses  an  approximate  dis-
                              -8
sociation constant (K.) of  10    M (Mistry et al.,  1982).   These data  quantify  the  high-affi-
nity nature of this protein for lead and explain the previously reported finding (Oskarsson  et
al., 1982) that this protein constitutes a major intracellular lead-binding site in  the kidney
cytosol.   Biochemical  studies  on the  protein components of isolated  rat  kidney  intranuclear
inclusion bodies have shown that the main component has an approximate  molecular weight of 27K
(Moore et al.,  1973)  or 32K (Shelton  and  Egle,  1982)  and that it is rich  in  two dicarboxylic
amino acids,  glutamate  and aspartate (Moore et al. , 1973).   The isoelectric point of the  main
nuclear  inclusion  body  protein has  been reported  to be  pi  =6.3 and appeared from two-dimen-
sional gel  analysis  to  be unique  to  nuclei  of lead-injected rats  (Shelton  and  Egle, 1982).
The importance of the inclusion bodies resides with the suggestion (Goyer et al., 1970a; Moore
et  al.,  1973;  Goyer and Rhyne, 1973)  that,  since  these structures contain the highest intra-
cellular  concentrations  of lead  in  the  kidney  proximal  tubule and  hence  account  for much  of
the total  cellular lead burden,  they  sequester  lead to some degree away from sensitive renal
organelles  or metabolic (e.g., heme biosynthetic)  pathways  until  their capacity is exceeded.
The same  argument would apply  to  the high-affinity cytosolic lead-binding proteins at  lead ex-
posure levels below  those that  cause  formation of inclusion bodies.   It  is currently unclear
whether  lead-binding  to these proteins  is an initial  step  in the  formation of the cytoplasmic
or  nuclear  inclusion  bodies (Oskarsson  et  al.,  1982).
12.5.5.3   Pathological  Features of  Lead Nephropathy.   The  main  morphological  effects of lead
in  the  kidney  are  manifested in renal  proximal tubule  cells  and interstitial  spaces between
the tubules.   A summary of morphological  findings from  some  recent  studies involving  a number
of  animal species is given  in Table 12-11.   In all  but  one of these studies, formation of  in-
tranuclear  inclusion bodies is a common pathognomic feature  for all species  examined.  In  ad-
dition,  proximal  tubule  cell  cytomegaly  and swollen mitochondria  with  increased  numbers of
lysosomes were also observed  in two of the chronic exposure studies  (Fowler et  al.,  1980; Spit
et  al.,  1981).  Another feature  reported in three of  these studies  (Mass  et  al.,  1964; White,
1977; Fowler  et  al.,  1980)  was  the  primary  localization  of  morphological  changes in  the
straight (S3) segments of  the proximal tubule, thereby  indicating  that not  all  cell  types of
the kidney are  equally  involved  in the toxicity of lead to this organ. Interstitial  fibrosis
 has also been  reported  in rabbits  (Hass et al., 1964) given diets containing 0.5 percent lead
 acetate  for up to 55 weeks and in rats (Goyer,  1971) given drinking water  containing lead ace-
 tate for 9 weeks.
 12.5.5.4  Functional Studies
 12.5.5.4.1   Renal  blood flow and glomerular filtration  rate.   Studies  by Aviv et  al.  (1980)
 concerning  the  impact of  lead  on  renal  function as  assessed by  renal  blood  flow (RBF)  and
 glomerular  filtration  rate (GFR)  have reported  significant  (p  <0.01) reductions  in both of
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                                           TABLE  12-11.   MORPHOLOGICAL FEATURES OF LEAD MEPHROPATHY IN VARIOUS SPECIES
CO
Species
Rabbit
Rat
Dog
Monkey
Rat
Rabbit
Ringed
dove

Nuclear
Pb dose regi*en inclusions
0.5X Pb acetate in +
diet for up to 55
weeks
IX Pb in drinking water +
for 9 weeks
50 ug/kg by gavage for +
5 weeks
0, 1.5, 6.0, 15 ugAiay *
in ad lib. drinking water
6 days/week for 9 months
0, 0.5, 5, 25, 50, 250 +
pp> in ad lib. drinking
water
0, 0.25, 0.50 MO/kg
by subcutaneous injection
3 days/wk for 14 weeks
100 ug/al +
in ad lib. drinking
water
Morphological findings*
1 ncreased
•itochondrial Increased
swelling Jysosomes
ND ND
+ ND
ND ND
NO ND
+
+
+

Interstitial
fibrosis Reference
+ Hass et al. (1964)
+ Goyer (1971)
ND White (1977)
ND Colle et al. (1980)
Fowler et al. (1980)
Spit et al. (1981)
Kendall et al. (1981)
              *HD = Not determined;  + = positive finding;  - =  negative  finding.

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these parameters  in rats at  3  and 16 weeks after  termination  of exposure to 1 percent  lead
acetate in  drinking water.   A statistically significant  (p  <0.05) reduction of GFR  has  also
been recently  described in dogs  2.5-4 hours  after a single i.v.  dose of lead at 3.0 mg/kg
(Victery et al.,  1981).   In contrast, studies by others  (Johnson and Kleinman,  1979; Hammond
et al., 1982) were not able to demonstrate a reduction in GFR or RBF using the rat  as  a model.
The  reasons  behind these  reported differences are  currently  unclear  but  may be  related  to
differences in experimental design, age of subjects, or other variables.
12.5.5.4.2  Tubular function.   Exposure to lead has also been reported to produce tubular  dys-
function  (Studnitz and Haeger-Aronsen, 1962;  Goyer,  1971;  Mouw et al.,  1978; Suketa et  al.,
1979;  Victery et  al.,  1981,  1982a,b,  1983).   An  early  study  (Studnitz  and Haeger-Aronsen,
1962)  reported  aminoaciduria  in rabbits given a  single  dose of lead at 125 mg/kg, with urine
collected over a 15-hour period.  Goyer et al.  (1970b) described aminoaciduria in rats follow-
ing  exposure  to 1 percent  lead acetate  in  the diet for  10  weeks.   Wapnir et al.  (1979)  con-
firmed  a  mild hyperaminoaciduria in  rats injected with lead at 20 mg/kg five times a week for
six  weeks but found no  changes in  urinary excretion of phosphate or glucose.
     Other  studies (Mouw  et  al., 1978;  Suketa  et al.,  1979; Victery  et al. , 1981,  1982a,b,
1983)  have focused  attention on  increased  urinary excretion  of electrolytes.    Mouw  et al.
(1978)  reported increased urinary excretion of  sodium,  potassium, calcium,  and water in dogs
given  a single intravenous injection  of  lead  at 0.6 or  3.0 mg/kg over a 4-hour period.  This
effect occurred  despite a constant GFR, which  indicates  decreased  tubular reabsorption of
these  substances.   Suketa et al.  (1979)  treated  rats with a single oral  dose of lead at 0, 5,
50,  or 200 mg/kg and killed the  animals at  0,  6,  12, or 24 hours after treatment.   A dose-
related increase in urinary  sodium,  potassium,  and water was observed over  time.  Victery et
al.  (1981, 1982a,b,  1983) studied  zinc  excretion in dogs  over  a 4-hour period  following an
intravenous injection of lead  at 0.3 or 3.0  mg/kg.  These  investigators reported maximal  in-
creases in zinc  excretion  of 140 ng/min  at the  0.3 mg/kg dose  and 300 ng/min at the  3.0 mg/kg
dose at the end  of the 4-hour period.   In contrast,  studies  by Mouw  et  al.  (1978)  showed no
changes in urinary excretion of  sodium or  potassium.   Urinary  protein and magnesium  excretion
were also unchanged.
      The results of the above studies indicate that acute or chronic lead treatment is  capable
of producing tubular dysfunction in various mammalian species,  as manifested by  increased  uri-
 nary excretion of  amino acid nitrogen, water, and  some  ions  such as Zn2 , Ca2  ,  Na  ,  and K .

 12.5.6  Experimental  Studies of the Biochemical  Aspects of  Lead Nephrotoxicity
 12.5.6.1  Membrane Marker Enzymes and Transport Functions.   The biochemical effects of lead in
 the kidney appear to be preferentially  localized  in  the cell  membranes and mitochondrial and
 nuclear compartments following either acute or chronic lead exposure regimens.
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     Oral exposure of  rats  to lead acetate in the  diet  at concentrations of 1-2 percent  for
10-40 weeks was  found  to produce no significant changes  in  the water content of  renal  slices
or in the accumulation of para-aminohippurate or tetraethyl-ammonium.   However,  tissue  glucose
synthesis  at  40  weeks  and  pyruvate  metabolism  were both  significantly  (p <0.05)  reduced
(Hirsch, 1973).
     Wapnir et al. (1979)  examined biochemical  effects in kidneys  of rats  injected with lead
acetate  (20 mg/kg) five days per week  for  six  weeks.   They observed  a  significant (p <0.05)
reduction in renal alkaline phosphatase activity and an increase in (Mg2  )-ATPase, but  no sig-
nificant changes  in  (Na ,K  )-ATPase,  glucose-6-phosphatase,  fructose  1-6 diphosphatase,  tryp-
tophan  hydroxylase,  or  succinic  dehydrogenase.   These  findings  indicated that  preferential
effects occurred  only  in marker enzymes localized  in  the  brush border membrane and mitochon-
drial inner membrane.  Suketa et al.  (1979)  reported marked (50-90 percent)  decreases in  renal
(Na  ,K )-ATPase at 6-24 hours following a single oral  administration of lead acetate at a dose
of 200 mg/kg.  A later study (Suketa et al.,  1981)  using this  regimen showed  marked decreases
in renal (Na ,  K )-ATPase but no significant changes in (Mg2  )-ATPase  after  24 hours, thus  in-
dicating  inhibition  of  a cell  membrane marker enzyme  prior   to  changes  in a mitochondrial
marker enzyme.
12.5.6.2   Mitochondrial  Respiration/Energy-Linked Transformation.   Effects of  lead on  renal
mitochondrial  structure  and function  have  been  studied  by a number  of  investigators  (Goyer,
1968; Goyer and Krall,  1969a,b; Fowler et al.,  1980, 1981a,b).   Examination  of proximal  tubule
cells of rats exposed  to drinking water containing 0.5-1.0  percent lead acetate  for 10  weeks
(Goyer, 1968; Goyer  and Krall, 1969a,b) or 250 ppm lead  acetate for  9 months (Fowler  et al. ,
1980) has  shown  swollen proximal  tubule cell mitochondria iji  situ.   Common biochemical  find-
ings  in  these  studies  were  decreases  in respiratory  control  ratios  (RCR) and inhibition  of
state-3 respiration,  which was  most  marked  for NAD-linked substrates  such as  pyruvate/malate.
Goyer and  Krall  (1969a,b) found  these  respiratory  effects  to  be associated  with a decreased
capacity of mitochondria to undergo energy-linked structural  transformation.
                                                             _4
     It)  vitro  studies  (Garcia-Canero et al.,  1981) using 10   M  lead demonstrated decreased
renal mitochondrial membrane transport of pyruvate or glutamate associated with  decreased res-
piration for these two substrates.  Other ui vitro studies (Fowler et  al.,  1981a,b)  have  shown
decreased  renal  mitochondrial  membrane energization  as measured  by the  fluorescent  probes
l-anilino,-8 napthalenesulfonic acid  (ANS)   or  ethidium  bromide  following  exposure to  lead
                               _5   _3
acetate at concentrations of 10  -10   M lead.   High amplitude  mitochondrial swelling was also
observed by light scattering.
     The results  of  the above studies indicate that lead produces mitochondrial swelling both
irj situ and jm  vitro,  associated with  a decrease  in  respiratory function that  is most marked

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for RCR and  state-3  respiration  values.   The structural and  respiratory  changes appear to  be
linked to lead-induced alteration of mitochondrial  membrane energization.
12.5.6.3  Renal Heme Biosynthesis.  There are  several  reports concerning the effects  of lead
on renal  heme  biosynthesis  following acute or chronic exposure (see Table 12-12).   Silbergeld
et al.  (1982)  injected  rats with lead at 10  umol/kg per day  for  three  days  and examined ef-
fects  on  several  tissues  including  kidney.    These  investigators found  an  increase  in
6-aminolevulinic  acid  synthetase (ALA-S) following  acute  injection  and  no  change  following
chronic exposure  (first  indirectly  via their dams' drinking water containing lead at 10 mg/ml
until  30  days of  age and  then  directly via  this drinking  water until  40-60  days  of age).
Renal  tissue  content  of  6-aminolevulinic acid (ALA) was increased in both acutely and chroni-
cally  exposed  rats.   Renal  6-aminolevulinic acid  dehydrase (ALA-D)  was  found to be inhibited
in both  acute and chronic treatment groups.  Gibson and Goldberg  (1970)  injected rabbits s.c.
with  lead acetate at doses of 0, 10,  30,  150, or 200  mg/week for up to 24 weeks.  The mito-
chondrial  enzyme  ALA-S  in  kidney was found  to show  no measurable  differences  from control
levels.   Renal  ALA-D,  which is  found  in the cytosol fraction, showed no differences from con-
trol  levels when glutathione was present but was significantly reduced (p <0.05) to 50 percent
of control  values for the pooled lead-treated  groups  when glutathione was absent.  Mitochon-
drial  heme  synthetase (ferrochelatase) was not significantly  decreased in lead-treated  versus
control  rabbits,  but  this  enzyme in  the kidney was inhibited by 72 and  94  percent at  lead-
                              _4        -3
acetate  concentrations of  10   and 10   M lead,  respectively.   Accumulation (12-15 fold) of
both  ALA and porphobilinogen (PBG) was also observed  in kidney tissue of lead-treated  rabbits
relative  to  controls.  Zawirska  and Medras  (1972)  injected  rats with  lead acetate at a  dose of
3  ing/day for  up  to  60  days and noted  a  similar renal  tissue accumulation of  uroporphyrin,
coproporphyrin,  and  protoporphyrin.   A  study by Fowler  et al.  (1980) using  rats  exposed
through  9 months  of age to  50  or  250 ppm lead acetate  in drinking water showed significant
inhibition  of the mitochondrial  enzymes ALA-S  and  ferrochelatase  but no change  in  the  activity
of  the cytosolic enzyme ALA-D.   Similar  findings  have been reported for  ALA-D  following acute
i.p.  injection of lead  acetate  at  doses of 5-100 mg/kg  at 16 hours prior to sacrifice (Woods
and  Fowler, 1982).   In  the latter  two studies, reduced  glutathione was  present in the assay
mixture.
      To summarize the above  studies,  the pattern  of  alteration  of  renal  heme  biosynthesis by
lead  is  somewhat  different from that usually observed  with  this agent  in other  tissues (see
Section  12.3).   In  general, renal  ALA-D does not  seem to  be inhibited much by  lead except
under conditions of  high-level  exposure  (Table 12-12).  Such  a  finding  could  result from the
presence of the recently described  high  affinity  cytosolic lead-binding  proteins (Oskarsson et
al.,  1982;   Mistry  et  al.,  1982)  in  the  kidney and/or the  formation  of  lead-containing
 intranuclear inclusion  bodies in this tissue (Goyer,  1971;  Fowler  et  al.,  1980), which would
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         TABLE 12-12.  EFFECTS OF LEAD EXPOSURE ON ASPECTS OF RENAL HEME BIOSYNTHESIS
Parameter Affected8
Species
Rabbit
Rat
Rat
Rat
(dams)
(newborns)
Rat
(dams)
(sucklings)
Rat
Rat
Rat

Pb dose regimen ALA-S ALA-D
10, 30, 150, 200 NC ±*
mg/kg per wk (s.c.)
3 mg/day NO NO
(s.c.)
10, 100, 1000, NO *
5000 ppm in
d.w. for 3 wks
10 ppm in d.w. ND NC
during:
3 wks before mating
3 wks of pregnancy
3 wks after delivery
ND NC
100 ppm in d.w. ND NC
for 3 wks
ND NC
0.5, 5, 25, 50, 250 * NC
ppm in d.w. for
9 months
5, 25, 50, 100 mg/kg ND NC
(i.p.) 16 hrs prior
to sacrifice
10 umol/kg/(i.p.) t 4-
for 3 days
10 mg/ml in d.w. NC *
for 10-30 days
Renal tissue
FC porphyrins
NC t ALA, PBG
(12-lSx)
ND t uro-,
copro- , proto-
porphyrins
ND t at 1000 and
5000 ppm;
t ALA-urine
ND NC
ND t
ND NC
ND t
4- ND
ND ND
ND t ALA
ND t ALA
Reference
Gibson and Gold-
berg (1970)
Zawirska and
Medras (1972)
Buchet et al.
(1976)
Hubermont
et al. (1976)

Reels et al.
(1977)

Fowler et al
(1980)
Woods and
Fowler (1982)
Silbergeld
et al. (1982)

 t = increased; 4. = decreased; ± = effect depends on
 relative to controls; ND = not determined.

 s.c. - subcutaneous; i.p. - intraperitoneal; d.w. -

CFC - ferrochelatase.
conditions of assay; NC = no change


drinking water.
                                          12-186

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sequester most  of the  intracellular  lead away  from other  organelle  compartments until  the
capacity of  these mechanisms is exceeded.  Based  on the observations of Gibson  and  Goldberg
(1970), tissue or assay concentrations of glutathione may also be of importance to the effects
of lead on this  enzyme.   The observed lack of ALA-S induction in kidney mitochondria  reported
in  the  above studies  may  have been  caused by  decreased  mitochondrial  protein  synthesis
capacity or,  as previously suggested (Fowler et al., 1980), by overwhelming inhibition of this
enzyme  by  lead,   such  that  any  inductive  effects  were  not  measurable.   Further  research is
needed to resolve these questions.
12.5.6.4  Alteration of Renal Nucleic Acid/Protein Synthesis.  A  number  of  studies have shown
marked  increases  in  renal  nucleic  acid or protein  synthesis following acute or chronic expo-
sure to  lead acetate.   One study (Choie  and  Richter,  1972a) conducted on rats given a single
intraperitoneal injection of lead acetate showed an increase in 3H-thymidine incorporation.  A
subsequent study  (Choie  and Richter,  1972b) involved rats given intraperitoneal injections of
1-7 mg  lead  once per week  over  a  6-month period.   Autoradiography of 3H-thymidine incorpora-
tion into tubule  cell  nuclei showed a 15-fold increase in proliferative activity in the lead-
treated  rats relative to controls.   The proliferative response  involved cells  both  with and
without  intranuclear  inclusions.   Follow-up  autoradiographic  studies in  rats  given three
intraperitoneal  injections   of  lead  acetate  (0.05  mg/kg)  48  hours  apart  showed  a 40-fold
increase  in  3H-thymidine incorporation 20 hours after the first lead  dose  and 6 hours after
the second and third doses.
     Choie and Richter (1974a) also studied mice given a single  intracardiac injection  of  lead
(5  ug/g) and demonstrated  a 45-fold maximal  increase in  DNA synthesis  in  proximal tubule
cells  as  judged by 3H-thymidine autoradiography 33  hours  later.  This  increase  in DNA  synthe-
sis was preceded by a general  increase  in both RNA and protein  synthesis (Choie and  Richter,
1974b).   The above findings were essentially confirmed with respect to  lead-induced  increases
in  nucleic   acid  synthesis  by Cihak  and Seifertova  (1976), who found  a 13-fold increase in
3H-thymidine incorporation  into kidney nuclei of  mice 4 hours  after an  intracardiac  injection
(5  pg/g)  of  lead  acetate.   This finding  was  associated  with  a  34-fold  increase  in the
mitotic index but  no change  in the  activities of thymidine kinase or thymide  monophosphate
kinase.   Stevenson  et al.  (1977) have  also reported  a  2-fold increase  in  3H-thymidine or
14C-orotic  acid  incorporation  into kidney DNA or  RNA  of  rats given a  single intraperitoneal
injection of lead chloride  three days earlier.
     The  above  studies  clearly demonstrate  that  acute or  chronic administration of  lead by
injection stimulates  renal  nucleic  acid  and protein  synthesis  in kidneys of  rats  and  mice.
The relationship between this proliferative  response and formation of  intranuclear  inclusion
bodies is  currently  unknown;  nor is  the basic  mechanism underlying  this  response  and the
formation of renal  adenomas  in  rats  and  mice following  chronic lead exposure  understood.
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12.5.6.5   Lead  Effects  on  the  RenirrAngiotension  System.   A study by Mouw et  al.  (1978)  used
dogs  given a single  intravenous  injection of lead  acetate  at doses of 0.6 or  3.0  mg/kg and
observed  over  a 4-hour  period.   Subjects  showed a small but  significant decrease  in plasma
renin activity  (PRA)  at 1  hour, followed  by  a  large and significant (p <0.05)  increase  from
2.5 to  4.0 hours.  Follow-up work (Goldman et al., 1981) using dogs given a single intravenous
injection  of  lead acetate  at  3.0 mg/kg  showed  changes in  the  renin-angiotensin  system  over
a 3-hour  period.  The  data  demonstrated an  increase  in  PRA, but increased  renin secretion oc-
curred  in only three of nine animals.  Hepatic extraction of renin was virtually eliminated in
all animals, thus  providing an explanation for the  increased  blood levels of renin.   Despite
the large observed increases  in  PRA, blood  levels  of  angiotensin II  (All) did not increase
after lead treatment.   This suggests that lead inhibited the All converting enzyme.
     Exposure of rats to drinking water containing 0.5 mg Pb/tnl for three weeks to five months
(Fleischer  et  al., 1980)  produced  an elevation  of  PRA after six weeks of exposure  in those
rats on a sodium-free diet.   No change in plasma renin  substrate (PRS)  was observed.   At  five
months, PRA was  significantly  higher in the lead-treated group on a 1-percent sodium chloride
diet,  but the  previous  difference  in renin levels  between  animals on an extremely low-sodium
(1 meq) versus  1-percent sodium diet had disappeared.   The lead-treated animals had  a reduced
ability to decrease sodium excretion following removal  of sodium from the diet.
     Victery et  al.  (1982a)  exposed rats to lead jri utero and to drinking  water solution  con-
taining 0, 100, or 500 ppm lead as  lead acetate  for six  months.  Male rats  on  the 100 ppm  lead
dose became significantly  hypertensive  at 3.5 months and  remained in that state until termi-
nation of the experiment at six months.   All female rats remained normotensive as did males at
the 500-ppm  dose level.   PRA was found  to be significantly reduced  in  the 100-ppm  treatment
males  and normal in the 500-ppm treatment groups of both males  and  females.   Dose-dependent
decreases  in  AII/PRA ratios and renal  renin  content were also observed.  Pulmonary  All  con-
verting enzyme  was  not significantly  altered.    It was concluded  that,  since  the  observed
hypertension in  the  100-ppm  group  of males was actually associated with reduction of PRA and
All, the  renin-angiotensin system was probably not directly involved in  this  effect.
     Webb  et  al.  (1981)  examined  the vascular  responsiveness  of  helical   strips  of  tail
arteries  in  rats exposed to drinking water containing  100 ppm lead  for seven months.  These
investigators found  that the  mild  hypertension   associated  with this  regimen was  associated
with increased vascular responsiveness to cradrenergic agonists.
     Male rats exposed  to  lead jji  utero and prior to weaning indirectly by their dams' drink-
ing water containing  0,  5,  or  25 ppm lead as  lead acetate, followed by  direct exposure at the
same levels for  five  months  (Victery et al.,  1982b), showed no change in systolic blood pres-
sure.    Rats exposed to  the 25  ppm dose  showed a  significant (p <0.05)  decrease in basal  PRA.
Stimulation of  renin  release  by  administration   of  polyethylene glycol showed  a significant
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increase in PRA  but  low All values.  These yielded  a significant (p <0.001) decrease  in  the
AII/PRA ratio.   Basal  renal  renin  concentrations were  found to be significantly  reduced  in
both the 5 ppm (p <0.05) and 25 ppm (p <0.01)  dose groups relative to controls.
     Victery et  al.  (1983)  exposed rats jjn utero  to lead by maternal  administration of 0,  5,
25, 100, or 500 ppm lead as lead acetate.   The animals were continued on their respective dose
levels through one month of age.  All  exposure  groups  had PRA values significantly (p <0.05)
elevated relative to  controls.   Renal renin concentration was found to be similar to controls
in  the 5  and  25 ppm  groups  but  significantly  increased (p  <0.05)  in  the  100 and  500  ppm
groups.  The plasma  AII/PRA ratio was similar to controls in the 100 ppm group but was signi-
ficantly reduced (p <0.05) in the 500 ppm group.
     It appears  from the above studies that  lead exposure at even low dose levels is capable
of  producing  marked  changes in the  renin-angiotension  system and that the direction and mag-
nitude of  these  changes  is mediated  by  a number  of factors, including dose level, age, and sex
of  the species  tested,  as well  as  dietary  sodium content.   Lead also appears  capable of
directly  altering  vascular responsiveness to ct-adrenergic agents.   The mild hypertension ob-
served  with chronic  low-level lead  exposure  appears to stem in  part from this  effect and not
from  changes in the  renin-angiotensin system.   (See also Section  12.9.1 and the Addendum to
this document for a  discussion of  other work on  the  hypertensive  effects  of  lead.)
12.5.6.6   Lead Effects on Uric Acid Metabolism.   A  report by Mahaffey et al.  (1981) on rats
exposed concurrently to lead,  cadmium,  and  arsenic alone or  in combination found significantly
(p  <0.05) increased serum concentrations of  uric acid  in the lead-only group.   While  the bio-
chemical  mechanism  of this effect  is not clear, these data support  certain observations in
humans concerning hyperuricemia as  a result  of  lead exposure (see  Section  12.5.3)  and, also,
confirm an earlier  report  by Goyer (1971)  showing  increased  serum  uric acid concentration in
rats  exposed to  1 percent lead acetate in drinking water for 84  weeks.
12.5.6.7    Lead  Effects on Kidney Vitamin D Metabolism.   Smith  et al.   (1981) fed  rats  vitamin
D-deficient diets containing either  low or  normal   calcium  or  phosphate for two weeks.   The
animals were  subsequently given  the same  diets  supplemented  with 0.82 percent  lead  as  lead
acetate.    Ingestion  of lead  at  this  dose level significantly reduced  plasma  levels  of  1,25
dihydrocholecalciferol in cholecalciferol-treated rats  and  in rats fed  either  a low phospho-
 rous  or  low calcium diet while it  had no  effect in rats fed either  a high calcium or normal
phosphorous diet.   These data suggest decreased production  of  1,25-dihydrocholecalciferol  in
 the  kidney in  response  to  lead exposure in  concert  with  dietary deficiencies.   These  and
 other data concerning  lead  effects on Vitamin-D metabolism were earlier discussed in detail
 in Section 12.3.
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12.5.7   General Summary:   Comparison of Lead's Effects  on  Kidneys  in  Humans and Animal Model*
     It  has  been  known  for  more than  a  century that  kidney  disease can  result  from  lead
poisoning.   Identifying the contributing causes and mechanisms of  lead-induced nephropathy has
been difficult,  however,  in  part  because  of  the  complexities  of  human  exposure  to lead  and
other nephrotoxic agents.   Nevertheless, it is possible  to  estimate  at least roughly the  range
of  lead exposure  associated  with  detectable renal dysfunction  in  both  human  adults  and
children.  Numerous studies of occupationally exposed workers have  provided evidence for  lead-
induced  chronic  nephropathy being associated with blood lead levels  ranging  from 40 to  more
than 100 ug/dl,  and  some are  suggestive of renal  effects possibly  occurring even  at levels as
low as 30 pg/dl.  In children, the relatively sparse  evidence available points to  the manifes-
tation  of  renal  dysfunction  only  at  quite  high blood lead  levels  (usually  exceeding  120
ug/dl).  The  current lack  of evidence for  renal  dysfunction  at  lower  blood lead levels  1n
children may simply  reflect the  greater clinical  concern with  neurotoxic effects of lead in-
toxication in  children.   The persistence  of  lead-induced  renal dysfunction in children  also
remains to be more fully investigated, although a  few studies  indicate that children diagnosed
as being acutely lead  poisoned  experience  lead nephropathy effects lasting throughout adult-
hood.
     Parallel  results  from experimental animal studies  reinforce  the findings  in humans  and
help  illuminate  the  mechanisms underlying such effects.   For example,  a number of transient
effects in human and animal renal  function  are consistent with experimental findings of rever-
sible  lesions  such  as  nuclear  inclusion   bodies,  cytomegaly,  swollen  mitochondria,   and
increased numbers of iron-containing lysosomes in  proximal  tubule  cells.   Irreversible lesions
such  as  interstitial fibrosis are also well  documented  in both humans and animals following
chronic exposure to high doses of lead.   Functional renal changes  observed in  humans have  also
been confirmed  in  animal model  systems with  respect  to  increased  excretion of amino acids and
elevated serum  urea  nitrogen and  uric acid  concentrations.  The inhibitory effects of  lead
exposure on renal blood flow and glomerular filtration rate are  currently  less clear in exper-
imental model  systems;  further research  is  needed  to  clarify  the effects  of  lead on  these
functional  parameters  in  animals.   Similarly,  while lead-induced perturbation  of the renin-
angiotensin  system  has  been  demonstrated  in  experimental  animal  models, further research  is
needed to clarify  the  exact relationships  among lead exposure (particularly chronic low-level
exposure),  alteration  of  the renin-angiotensin  system,  and hypertension  in  both humans  and
animals.
     On the biochemical level,  it appears  that lead  exposure produces changes  at a number of
sites.   Inhibition of  membrane  marker enzymes, decreased mitochondrial  respiratory function/
cellular energy  production,  inhibition  of renal  heme biosynthesis, and altered  nucleic  acid

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synthesis are the most  marked  changes to have been reported.   The extent to which these mito-
chondria! alterations occur  is  probably  mediated in part by the intracellular bioavailability
of  lead,  which  is  determined  by its  binding  to high affinity kidney cytosolic  proteins  and
deposition within intranuclear inclusion  bodies.
     Among the questions  remaining  to be answered more definitively about the effects  of lead
on the kidneys is the lowest blood lead level at which renal effects occur.   In this regard it
should be  noted  that recent studies in  humans  have indicated that the EDTA lead-mobilization
test  is  the most  reliable  technique  for  detecting persons at risk  for chronic  nephropathy;
blood  lead measurements  are a  less  satisfactory  indicator  because  they may  not accurately
reflect  cumulative  absorption  some  time after exposure to lead  has  terminated.   Other ques-
tions include the following:  Can a distinctive  lead-induced renal lesion be identified either
in  functional or histologic terms?  What biologic  measurements are most reliable for the pre-
diction  of lead-induced nephropathy?   What is the  incidence of  lead nephropathy in the general
population as well  as among  specifically defined subgroups with varying  exposure?  What is the
natural  history  of  treated  and untreated  lead  nephropathy?  What is  the  mechanism of lead-
induced  hypertension and  renal  injury?  What are the  contributions of environmental and genet-
ic  factors to the  appearance  of  renal  injury  due to  lead?   Conversely,  the most difficult
question of  all  may well be to determine the contribution of  low levels of lead exposure to
renal disease of  non-lead etiologies.
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12.6 EFFECTS OF LEAD ON REPRODUCTION AND DEVELOPMENT
     Studies of humans  and animals indicate that lead may exert gametotoxic, embryotoxic, and
teratogenic  effects  that could influence  the  survival  and development of the  fetus  and new-
born.  It  appears  that prenatal viability  and  development may also be  indirectly  affected by
lead through its effects on the health of the expectant mother.   The vulnerability of the con-
ceptus to  such  effects  has contributed to  concern  that the unborn may constitute a  group at
risk for the effects of lead on health.  Also,  certain information regarding male reproductive
functions has led to concern regarding the impact of lead on men.

12.6.1 Human Studies
12.6.1.1   Historical Evidence.  Findings  suggesting that lead exerts adverse effects on human
reproductive  functions  have existed in the  literature  since before the turn of  the century.
For  example,  Paul (1860)  observed that  severely lead-poisoned pregnant women  were  likely to
abort, while those  less  severely  intoxicated  were  more  likely to  deliver  stillborn infants.
Legge  (1901),  in  summarizing  the  reports of 11  English factory inspectors,  found that of 212
pregnancies in 77 female lead workers, only 61 viable children were produced.  Fifteen workers
never  became  pregnant;  21 stillbirths and 90 miscarriages occurred.  Of 101 children born, 40
died  in  the  first year.   Legge also  noted that  when lead was fed to  pregnant animals, they
typically aborted.  He concluded that maternal  exposure to lead resulted in a direct action of
the element on the fetus.
     Four years later, Hall and Cantab (1905) discussed the increasing use of lead in nostrums
sold as abortifacients in Britain.   Nine previous reports of the use of diachylon ("lead plas-
ter")  in  attempts to cause miscarriage were  cited,  along with 30 further  cases  of  known or
apparent use  of  lead in attempts   to terminate real  or suspected pregnancy.   Of  22  cases de-
scribed in  detail,  12  resulted in miscarriage and  all  12 exhibited marked signs of plumbism,
including a blue gum line.  In eight of these cases, the women were known to have attempted to
induce abortion.   Hall  and Cantab1s report was  soon followed  by those of  Cadman (1905) and
Eales  (1905),  who described  three more women who  miscarried  following consumption  of lead-
containing pills.
     Oliver  (1911)  then published  statistics  on the  effect of lead on pregnancy in Britain
(Table 12-13).   These figures showed  that  the miscarriage rate was elevated among  women em-
ployed in  industries  in which they were exposed to lead.  Lead compounds were said by Taussig
(1936) to  be  known for  their embryotoxic  properties  and their use to  induce abortion.   In a
more recent  study  by Lane (1949),  women exposed to air lead levels of 750 M9/I"3 were examined
for effects on reproduction.  Longitudinal data on 15 pregnancies indicated an increase in the
number of  stillbirths and abortions.   No data were  given on urinary lead in these women, but
men in this sample had urinary levels of 75-100 pg/liter.
                                           12-192

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                  TABLE 12-13.   STATISTICS  ON  THE EFFECT  OF  LEAD  ON  PREGNANCY
                                              Number of                        Number  of
                                            abortions and                   neonatal deaths
                                           stillbirths per                 (first  year) per
Sample                                      1000 females                     1000  females
Housewives                                       43.2                             150
Female workers (mill  work)                       47.6                             214
Females exposed to lead premaritally             86.0                             157
Females exposed to lead after marriage          133.5                             271

Source:  Oliver (1911).

     The above  studies clearly  indicate an adverse effect of lead at high levels  on human re-
productive  functions,  particularly miscarriages  and stillbirths, when  women are  exposed  to
lead during  pregnancy.   Although the mechanisms underlying  these  effects  are unknown at this
time,  many  factors  could  contribute  to  such  results.   These  factors  range from  indirect
effects  of lead  on  maternal  nutrition  or  hormonal  state before or during  pregnancy to more
direct  gametotoxic,  embryotoxic,  fetotoxic, or teratogenic effects that could affect parental
fertility  or offspring  viability  during gestation.   Pregnancy is a stress  that may place a
woman  at higher  risk  for  lead  toxicity, because both  iron  deficiency  and calcium deficiency
increase  susceptibility to lead, and women have an  increased risk of both deficiencies during
pregnancy  and postparturition (Rom, 1976).
     Early  studies from the turn of the  century generally suffer  from methodological  inadequa-
cies.   They must be mentioned,  however, because they  provide evidence that effects of lead on
reproduction  occurred  at times when women  were exposed  to high levels of  lead.   Nevertheless,
evidence  for adverse  reproductive outcomes in  women with obvious lead poisoning is  of little
help in defining  the effects of  lead at  much  lower  exposure  levels.  Efforts  have been made to
define more precisely  the points  at which  lead may affect  reproductive functions  in both the
human  female  and  male, as  well as  in animals, as  reviewed below.
12.6.1.2   Effects of Lead  Exposure on  Reproduction
12.6.1.2.1  Effects associated with exposure of women to lead.    Since  the time  of the  above
reports,  women have been  largely,  though  not entirely (Khera et  al., 1980),  excluded from oc-
cupational  exposure to  lead;  also,  lead is no longer used  to  induce abortion.   Thus,  little
new information  is  available  on  reproductive  effects  of chronic  exposure of women to  lead.
Various reports  (Pearl  and Boxt,  1980;  Qazi  et al.,  1980;  Timpo et al. , 1979;  Singh et al. ,
1978;  Angle  and  Mclntire, 1964)  suggest that  relatively  high  prenatal  lead  exposures  do  not
 invariably result in  abortion or  in major problems  readily detectable  in the first  few years
of life.
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These findings are  based  on only a few case histories, however,  and are obviously not an ade-
quate  sample.   The  data  are  confounded  by  numerous  variables,  and  longer follow-ups  are
needed.
     In a  sample  population exposed to lead as well  as other toxic agents  from  the  Rbnnskar
smelter  in Sweden,  Nordstrom et  al.   (1978b)  found  an increased  frequency of  spontaneous
abortions  among women  living  closest to the smelter.   In addition to the exposure to  multiple
environmental   toxins,  however,  the study  was confounded  by failure  to  match   exposed  and
control populations  for socioeconomic  status,  which could also bear  upon the women's health.
A further  study by  the same authors (Nordstrom et  al., 1979a) determined that female workers
at the  Rb'nnskar smelter  had an increased frequency of spontaneous miscarriage when the mother
was employed by the smelter during pregnancy or  had  been so employed prior  to pregnancy  and
still  lived  near  the  smelter.   Also,  women who  worked in  more  highly polluted areas  of  the
smelter were  more  likely to  have  aborted  than  were other employees.  This  report,  however,
suffers from the same deficiencies as the earlier study.
     With  regard  to potential effects  of  lead  on  ovarian  function in human females,  Panova
(1972)  reported a  study  of  140 women working in  a printing  plant for less than one year (1-12
months) where ambient air levels  were under 7 ug  Pb/m3.  Using a  classification of various age
groups  (20-25,  26-35, and 36-40 yr) and type of ovarian cycle (normal,  anovular,  and disturbed
lutein  phase), Panova  claimed  that statistically significant differences  existed  between  the
lead-exposed and  control  groups  in the age range 20-25 years.  Panova1s report,  however, does
not show the age  distribution,  the level of  significance,  or data on the  specificity  of  her
method  for classification.   Zielhuis and  Wibowo (1976),  in a critical  review of the above
study, concluded that the study design and presentation of data were such that it is difficult
to evaluate the author's conclusions.  It should  also be noted that no consideration was given
to the dust levels of lead,  an important factor in print shops.
     No other  information  is available  for assessing  the  effects  of  lead  on  human ovarian
function or other  factors affecting female fertility.  Studies offering firm data on maternal
variables,  e.g.,  hormonal  state,  that are known to affect the ability of the pregnant  woman to
carry the fetus full term are also lacking.
12.6.1.2.2  Effects associated with exposure of men to lead.   Lead-induced effects on  male re-
productive functions have been reported in several instances.   Among the earliest of these was
the review of  Stofen (1974),  who described data  from the work of Neskov in the USSR involving
66 workers exposed  chiefly  to lead-containing gasoline (organic lead).   In 58 men there was a
decrease or disappearance of  erection,  in 41 there was early ejaculation, and in 44 there was
a diminished number of spermatocytes.  These results were confounded, however, by the presence
of the other constituents of gasoline.
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     Lancranjan et al.  (1975)  reported  lead-related interference with  male  reproductive  func-
tions.   A  group of  150 workmen who  had  long-term exposure  to lead  in  varying degrees was
studied.   Clinical  and  toxicological  criteria  were  used  to  categorize  the  men  into  four
groups: lead-poisoned workmen  (mean  blood lead level  =  74.5 ug/dl)  and those  showing  moderate
(52.8  ug/dl),  slight (41  ug/dl),  or "physiologic" (23  ugAH) exposure to lead.   Moderately
increased  lead  absorption  (52.8 M9/dl)  was said to result in gonadal  impairment.  The effects
on  the testes were  believed  to be  direct,  in  that  tests  for  impaired  hypothalamopituitary
influence  were  negative.   Also, semen analysis revealed asthenospermia and  hypospermia in all
groups except those with "physiologic" absorption levels, and increased teratospermia  was seen
in the two highest lead exposure groups.
     An  apparently  exposure-related increase   in  erectile  dysfunction  was  also  found  by
Lancranjan et al. (1975).  Problems with ejaculation and libido were said  to be more common in
the lead-exposed groups, but the incidence of such problems  did not seem to  be dose-dependent.
The  frequency of these problems in  a  control  group was  invariably lower than  in the  lead-
exposed groups, however, so the lack of a clear-cut dose-response relationship may have merely
been due  to  inappropriate assignment of  individuals  to the  high,  moderate,  and low-exposure
groups.
     The Lancranjan et  al. (1975) study has been criticized by Zielhuis and Wibowo (1976), who
stated that the distributions  of  blood  lead  levels  appeared to be skewed and that  exposure
groups overlapped  in terms of  lead  intake.  Thus,  the  means for each putative exposure group
may  not have been representative of  the  individuals  within a group.  It is difficult to dis-
cern,  however,  if the  men were improperly  assigned  to exposure level groups,  as  blood lead
levels may have varied considerably on  a short-term basis.  Zielhuis  and  Wibowo also stated
that the measured urinary ALA  levels were  unrealistically high for  individuals with the stated
blood  lead levels.   This suggests that if the ALA values were correct, the blood lead levels
may  have  been  underestimated.   Other deficiencies of  the  study  include the  failure to use
matched controls  and the exclusion  of different proportions  of  individuals per exposure group
for the semen analyses.
     Plechaty et  al.   (1977)  measured  lead concentrations in  the  semen of  21  healthy men.
Semen  lead levels were  generally less than blood lead levels, and no correlation  was  found be-
tween  lead content of  the semen and sperm counts or blood lead levels in  this  small sample.
     Hypothalamic-pituitary-testicular  relationships were  investigated by Braunstein et al.
(1978) in men  occupationally  exposed at  a lead smelter.  Six subjects  had  2-11 years of  expo-
sure  to  lead and exhibited  marked  symptoms of lead toxicity.   All  had  received one or  more
courses of EDTA chelation therapy.   This group was referred to as  "lead-poisoned"  (LP).   Four
men from  the same smelter had no  signs  of  lead toxicity,  but had  been exposed for 1-23 years
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and were designated  "lead-exposed"  (LE).   The control  (C)  group  consisted of nine volunteers
whose  socioeconomic  status was  similar to the  lead workers.  Mean  (±  standard  error)  blood
lead levels  for  the  LP,  LE, and C groups were 38.7 (± 3), 29.0 (± 5), and 16.1 (± 1.7) ug/dl,
respectively, at  the  time  of the study.   Previously,  however,  the LP and LE groups had exhi-
bited  values  as  high as 88.2  (± 4)  and 80 (± 0) |jg/dl, respectively.   All  three  groups were
chelated  and 24-hour  urinary lead  excretion values  were  999 (± 141),  332 (± 17),  and 225
(± 31) |jg  for  the LP, LE,  and C  groups,  respectively.  Frequency of intercourse was signifi-
cantly  less  in both  lead-exposed groups  than in controls.    Sperm concentrations  in semen of
the LP  and LE  men ranged  from normal  to  severely oligospermic, and one from the LP group was
unable  to  ejaculate.   Testicular biopsies  were  performed on "the  two most  severely  lead-
poisoned men,"  one with aspermia  and  one  with testicular  pain.   Both men  showed increased
peritubular fibrosis, decreased spermatogenesis, and Sertoli cell  vacuolization.  The two lead
groups exhibited  reduced basal  serum testosterone levels,  but  displayed a normal  increase in
serum  testosterone following  stimulation  with human chorionic  gonadotrophin.   A  similar rise
in serum follicle-stimulating  hormone was seen following treatment with clomiphene citrate or
gonadotrophin-releasing hormone, although  the LP men exhibited a lower-than-expected increase
in luteinizing hormone  (LH).   The LE men also appeared to have a reduced LH response, but the
decrease was not significant.
     The results  of  the Braunstein  et al.  (1978) study  suggest that  lead  exposure at high
levels  may result in  a  defect  in  regulation of  LH  secretion at  the hypothalamic-pituitary
level.   They also indicate a likely direct effect on the testes, resulting in oligospermia and
peritubular fibrosis.  However, the number of subjects  in the study was quite small, and there
is  also a possibility that  the  observed effects  were precipitated  by the  EDTA chelation
therapy.
     More  recently,  Wildt  et al.  (1983)  compared  two groups of men  exposed to  lead  in  a
Swedish battery  factory.   The high-lead men had had blood lead levels ^50 ug/dl at  least once
prior  to   the  study, while  the  "controls"   seldom  exceeded 30  ug/dl.   There were  two test
periods, in  the  fall  and the following spring.   For  the first test,  14 men in the high-lead
group  and  23  in  the control group were examined;  16 were  in  each  group for the second test.
Fourteen and 15 of these men from the high-lead and control groups, respectively, took part in
both tests.   Blood lead values  were  obtained periodically over  a  six-month  period.  For the
two high-lead groups, blood lead values were 46.1 and 44.6 ug/dl,  respectively  (range: 25-75);
corresponding values  for the controls were 31.1  and  21.5 ug/dl (range:  8-39).  The high-lead
men tended to  exhibit decreased function of the prostate and/or  seminal vesicles, as measured
by seminal plasma constituents (fructose, acid  phosphatase,  magnesium,  and zinc);  however, a
significant difference was seen  only in  the  case  of zinc.   More men in the high-lead than  in

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the control group  had  low semen volumes, but  the  number of subjects did not allow a reliable
statistical analysis.  The  heads  of sperm of  high-lead  individuals  were more likely to swell
when exposed to  a  detergent solution, sodium  dodecyl  sulfate  (SDS), which constituted a test
of  functional  maturity,  but the  results were  still  in the  normal range.  Conversely,  the
leakage of  lactate dehydrogenase  isoenzyme  X (LDH-X) was  greater  in control  semen samples.
     The values  for live  and  motile sperm  were lower  in  the control  group.  The  data  were
skewed, however, by the presence of some of the same men  with low values  in the  control groups
for  both  sampling  times.    Another  confounding  factor  was  the fact  that the high-lead  and
control groups  differed in  a  significant way:   ten of  the control men  had current  or past
urogenital  tract infections  versus none in the high-lead group, possibly explaining the inci-
dence  of control samples  with  lowered sperm motility and viability.   The observed decrease in
SDS resistance in the sperm of high-lead-group men may have been related to their apparent ab-
normal  prostatic  function or  to  an  effect  of  lead  on  sperm  maturation.   In  evaluating the
above  results of Wildt et al.  (1983) it  must also be noted that even the "controls" had ele-
vated  blood lead levels.
     When Smith  et al.  (1983)  compared blood  lead  levels in a sample of  80 infertile and 38
fertile men, no  differences were  seen between the two groups.  Also, in a sample of 15 normal
and  16 vasectomized men,  Butrimovitz et al. (1983) found no relationship between seminal lead
and sperm count or motility.  Lead levels were relatively low (3.8 and 4.1 ug/dl in the intact
and  vasectomized males,  respectively),  however,  and such a  result is not unexpected.  At much
higher levels (66-139 ug/dl), five of seven  lead-poisoned men examined by Cullen et al. (1984)
showed abnormal spermatogenesis, particularly  oligospermia and  azoospermia.  Chelation therapy
produced only partial improvement  in these patients.
12.6.1.3   Placental  Transfer of Lead.   The  transfer of  lead across  the  human placenta and the
consequent  potential  threat to  the conceptus have been recognized for more  than a century
(Paul,  1860).   Documentation of placental transfer of lead  to  the fetus and data on resulting
fetal  blood  lead levels suggest a potential,  but as yet not clearly defined, threat of subtle
embryotoxicity or  other deleterious  health effects.
     The  placental transfer of  lead has  been  established,  in part,  by various studies that
have  disclosed measurable  quantities of lead in human  fetuses or  newborns,  as  well as off-
spring of  experimental  animals.    The relevant data on prenatal lead absorption have  been re-
viewed in  Chapter  10, Section 10.2.4 of this document,   and  thus  work dealing  only with lead
levels will not  be discussed further here.
12.6.1.4   Effects  of Lead  on the  Developing  Human
12.6.1.4.1   Effects of lead exposure on fetal  metabolism.  Prenatal  exposure of  the conceptus
to lead,  even  in the absence  of  overt  teratogenicity, may  be  associated with  biochemical
effects.   This  is suggested by  studies relating  fetal  and cord-blood levels to  changes  in
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enzymes  and  precursors related  to  fetal heme  synthesis.    Haas et  al.  (1972)  examined  294
mother-infant pairs for blood  lead  and urinary ALA  levels.   The maternal  blood lead  mean  was
16.89 M9/dl, while  the fetal  blood lead mean was  14.98 pg/dl,  with a correlation coefficient
of 0.54  (p <0.001).   In the infants, blood  lead  levels and urinary ALA were  positively cor-
related (r = 0.19, p <0.01), although the data were based on spot urines  (which tends  to limit
their value).  The  full  biological  significance of the  elevated ALA  levels is not clear,  but
the positive correlation  between lead in blood and urinary ALA for  the group as a whole indi-
cates increased potential  for impairment of heme synthesis at relatively  low blood lead levels
in the fetus or newborn infant.
     Subsequently,  Kuhnert  et  al.   (1977)  measured ALA-D  activity  and levels  of erythrocyte
lead in pregnant urban women and their newborn offspring.  Cord erythrocyte lead levels ranged
from 16 to 67 ug/dl of cells,  with a mean of 32.9.   Lead levels were inversely correlated with
ALA-D activity (r = -0.58, p <0.01), suggesting that typical urban lead exposures could affect
fetal enzyme activity.  Note,  however, that ALA-D activity is related to  blood cell age and is
highest  in the younger cells.   Thus, results obtained  with cord blood,  with its high percen-
tage of  immature  cells,  are not directly comparable to those obtained with adult blood.  In a
later  study,  Lauwerys et al.  (1978)  found  no lead-related  increase  in erythrocyte porphyrin
levels  in  500  mothers  or their offspring.   They  did,  however,  report negative correlations
between  ALA-D  activity and blood  lead  levels  in  both mothers  and their  newborns.   Maternal
blood  lead levels  averaged  10.2 |ag/dl, with a range of 3.1-31 ug/dl;  corresponding values  for
the newborns were 8.4 H9/dl  and 2.7-27.3 M9/dl-   Such results indicate that ALA-D activity  may
be a more sensitive indicator of fetal lead toxicity than erythrocyte porphyrin or urinary  ALA
levels.
12.6.1.4.2   Other toxic effects of  intrauterine lead exposure.    Fahim et  al.  (1976),  in  a
study  on maternal and  cord-blood  lead  levels,  determined blood lead values  in women having
preterm delivery and premature membrane rupture.  Such women residing in a "lead belt" (mining
and  smelting area)  had significantly higher blood  lead levels than women  from  the same area
delivering at full  term.   Fahim et al.  (1976)  also  noted that  among  249  pregnant women in a
control  group outside the lead belt area, the  percentages of women having preterm deliveries
and  premature  rupture were 3.0 and  0.4,  respectively, whereas  corresponding  values  for  the
lead area  (n =  253)  were 13.04 and  16.99,  respectively.   A confusing aspect  of this study,
however,  is  the   similarity of  blood  lead  levels  in women  from  the  presumptive low-lead  and
lead belt areas.   In fact, no evidence was presented that women in the lead belt group had  ac-
tually received  a greater degree of lead exposure  during pregnancy than did control  individ-
uals.  Also, questions exist  regarding analytical  aspects of this study.   Specifically, other
workers  (e.g.,  see summary table  in  Clark,  1977)  have typically  found blood  lead levels in
mothers and their newborn offspring to be much more similar than those of Fahim et al. (1976).
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     In another  study,  Clark  (1977) detected no effects of prenatal lead exposure in newborns
with regard  to birth weight,  hemoglobin, or  hematocrit.   He  compared  children born  of 122
mothers living near  a Zambian lead mine with 31 controls from another area.   Maternal  and in-
fant blood lead  levels  for the mine area  were  41.2 (± 14.4) and 37.9 (± 15.3) ug/dl,  respec-
tively.  Corresponding  values  for  control  mothers and offspring were 14.7 (± 7.5) and 11.8 (±
5.6) jig/dl.
     Nordstrb'm et al. (1979b)  examined birth weight records for offspring of female employees
of a Swedish  smelter and found decreased birth weights related to the following:   (1) employ-
ment of the  mothers  at  the smelter during pregnancy; (2) distance that the mothers lived from
the smelter;  and (3) proximity of  the  mother's job to the actual  smelting  process.   Similar
results were  also seen  for children born to mothers merely living near the smelter (Nordstrb'm
et al., 1978a).   Nordstrom et al.  (1979b) also investigated birth defects in offspring of the
female smelter workers  and in populations living at various distances from the smelter.  They
concluded that the  frequencies of  both single  and  multiple malformations were increased when
the mother worked at the smelter during pregnancy.
     The number of smelter workers with malformed offspring was relatively small (39 of 1291).
The incidence  of children with birth defects whose mothers worked while pregnant was 5.8 per-
cent (17 of  291).   Five of the six offspring  with multiple malformations were in this group,
suggesting that  the  observed  effect may have been a real one.  Nevertheless, a crucial factor
in evaluating  all of these results  is  the exposure of workers and the nearby population to a
number of toxic substances, including not only  lead, but arsenic, mercury, cadmium, and sulfur
dioxide as well.
     Alexander and Delves (1981) found that the mean blood  lead concentrations of pregnant and
non-pregnant women  living in  an urban  area  of  England were approximately 4 ug/dl higher than
those  for similar groups living in  a  rural  area.  The mean  concentrations  for the urban and
rural  pregnant women were  15.9 and 11.9  ug/dl, respectively  (p <0.001),  but there  were no
demonstrable  effects of  the  higher maternal   blood  lead  levels  on any  aspect  of perinatal
health.  The rate for  congenital   abnormality  was  higher  in the  rural  area,  suggesting that
whatever the cause,  it was unlikely  to  be  related to maternal levels of lead.
     Khera  et al.   (1980)  measured placental  and  stillbirth  tissue lead  in occupationally
exposed women in the United  Kingdom.   Regardless  of  the  incidence of stillbirths, placental
lead concentrations  were found to  increase  with  duration of occupational exposure, from 0.29
ug/g at <1  year exposure to 0.48 ug/g  at  >6 years  exposure for a  group of 26 women  aged  20-29
years. Placental  lead concentrations also increased  with  age of  the mother,  independently of
time of occupational exposure, and  ranged from 0.30 (± 0.16)  ug/g for those  <20 years old to
0.51 (±0.44)  ug/g for those £30 years  old.   Average placental  lead concentrations for  20  occu-
pationally exposed women  whose babies were stillborn were  higher  [0.45 (± 0.32) ug/g]  than the
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average level  [0.29  (±  0.09) |jg/g] for placentas  from eight mothers who had not been occupa-
tional ly exposed for at least two years.   The authors noted, however, that it was not possible
to  say  whether occupational  exposure caused any of the stillbirths or whether  the  high lead
levels  were  merely consequential  to  the fetal  death.   Interpretation of this  study  is also
somewhat complicated by  the  fact that the average placental lead concentration was about one-
third that  reported earlier by  this  group  (Wibberley et al., 1977).  These  differences were
attributed to methodological  changes and to changes in concentration during storage of placen-
tas at -20°C (Khera et al., 1980).
     A  study  by Roels  et  al.   (1978b)  reported placental  lead  values of 0.08  (± 0.05) ug/g
(range = 0.01-0.40 pg/g) from  a variety of locations  in  Belgium,  but these  data indicated no
correlation between lead concentration and birth weight.  In contrast, placental  lead has been
reported to  be associated with decreased activity  of a placental  enzyme,  steroid sulfatase
(Karp  and  Robertson, 1977).   A similar  association  was found  for mercury,  suggesting that
either metal or  both together  could have affected the enzyme activity or that the authors had
merely uncovered a spurious correlation.   There is also some evidence that lead levels in bone
samples from  stillborn  children  are  higher than  would otherwise be expected (Khera  et al.,
1980; Bryce-Smith  et al.,  1977),  but the data are inconclusive.   (See the  Addendum  to this
document for a  discussion  of more recent evidence concerning possible effects of intrauterine
lead exposure on prenatal and postnatal development in children.)
12.6.1.4.3  Paternally mediated effects of lead.   There is  increasing evidence  that exposure
of male laboratory  animals to  toxic agents can result in adverse effects on their offspring,
including decreased litter size, birth weight,  and survival  (see Section 12.6.2.2.1).  Mutage-
nic effects are the most likely cause of such results, but other mechanisms have been proposed
(Soyka and Joffe, 1980).   In the following cases, exposure of human males to  lead has been im-
plicated as the cause of adverse effects on the conceptus.
     According to Koinuma (1926) in a brief report, 24.7 percent of workmen exposed to lead in
a storage battery  plant  had childless marriages,  while  the value for men not so exposed was
14.8 percent.   Rates for miscarriages or stillbirths in wives of lead-exposed men and controls
were 8.2 and 2.8 percent,  respectively,  while  corresponding  figures  for neonatal deaths were
24.2 and 19.2  percent.   The comparisons were  based  on 170  lead-exposed and  128 control men.
These differences in fertility  and prenatal  mortality, while not dramatic,  are suggestive of a
male-mediated lead effect;  however, the reliability of the methodology used in this study can-
not be determined, due to the brevity of the report.
     In a study of the pregnancies of 104 Japanese women before and after their husbands began
lead-smelter work,  miscarriages increased to  8.3  percent of pregnancies  from a pre-exposure
rate of  4.7 percent  (Nogaki,  1957).   The miscarriage rate for 75 women  whose  husbands were
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not  occupationally exposed  to  lead  was  5.8 percent.   In  addition,  exposure  to  lead  was
related to  a significant  increase  in the ratio  of  male to female offspring at  birth.   Lead
content of paternal blood  ranged from 11 to  51.7 pg/dl  [mean = 25.4 (± 1.26) ug/dl],  but was
not correlated with reproductive outcome,  except in the  case of the male-to-female  offspring
ratio.   The  reported  blood lead levels appear low, however, in view of the occupational  expo-
sure of  these men, and  were  similar  to  those   given  for  controls  [mean =  22.8 (± 1.63)
jjg/dl].  Also,  maternal age  and parity appear  not  to  have  been well controlled for  in the
analysis of the data on reproductive outcome.   Another report (Van Assen,  1958) on fatal  birth
defects in children conceived during a period when their father was lead-poisoned (but neither
before nor after)  also suggests but does not clearly  demonstrate paternally-mediated effects
of lead.
     In  the   study  by Nordstrom  et  al.  (1979b),  women  employed  at  the  Rb'nnskar smelter in
Sweden were found to have higher miscarriage rates if their husbands were also employed at the
smelter.   This was true only of  their third or later pregnancies, however, suggesting that the
effect was related to  long-term  exposure of the male gametogenic stem cells.  Whether this was
a lead effect or that  of other  toxins from the smelter is not clear.
12.6.1.5  Summary of the Human  Data.  The literature on the effects of lead on human reproduc-
tion and development  leaves little doubt that lead can, at high exposure levels, exert signi-
ficant adverse health  effects on reproductive functions.  Most studies, however, only examined
the effects of prolonged moderate to high exposure to lead, such as that encountered in indus-
trial  situations,  and many reports do  not provide definite information on exposure levels or
blood  lead  levels  at which specific effects  were observed.   Also, the human  data were largely
derived  from studies  involving relatively small numbers of  individuals  and therefore do not
allow  for discriminating statistical analysis.  These reports are  often additionally confound-
ed by  the failure to  include appropriate controls and, in some cases, by the  presence of  addi-
tional toxic agents or disease  states.  These and other  factors obviously make interpretation
of the data  difficult.  Based  on the  Lancranjan  et al. (1975) and  Wildt et al. (1983) studies,
it  appears  possible that  effects on  sperm or the testis may result from chronic exposure at
blood  lead  values of 40-50 ug/dl,  but  additional  data are greatly  needed.   Exposure  data
related  to  reproductive functions  in  the  female are so  lacking  that  even a  rough estimate is
impossible.   Data  on  maternal  exposure  levels at which effects may be  seen  in human  fetuses or
infants  are  also  quite meager or equivocal.   However, the  results  of Haas  et al.   (1972),
Kuhnert  et  al.  (1977), and  Lauwerys  et al.   (1978)  suggest  possible  perinatal effects  on heme
metabolism  at maternal blood  levels considerably below 30 ug/dl.   [More  recent  studies  dealing
with the effects of  relatively low-level  lead exposure  on  development  both prenatally (e.g.,
congenital  anomalies,  birth  weight,  gestational age)  and  postnatally  (e.g.,  infant  mental
development,  child stature) are reviewed in  an Addendum to this document.]
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12.6.2 Animal Studies
12.6.2.1  Effects of Lead on Reproduction
12.6.2.1.1  Effects of lead on male reproductive functions.  Among the  first  investigators  to
report infertility  in  male  animals due to lead exposure were Puhac et al.  (1963),  who exposed
rats to  lead  via their diet.   Ability to sire offspring returned, however,  45 days after ces-
sation of treatment.  More recently, Varma et al.  (1974) gave a solution of lead subacetate  in
drinking water to  male Swiss  mice for four weeks  (mean total  intake of lead  = 1.65 g).  The
fertility of  treated males was  reduced by  50 percent.   Varma  and coworkers  calculated the
mutagenicity index  (number  of  early fetal  deaths/total  implants)  to  be 10.4  for lead-treated
mice versus  2.98  for controls  (p <0.05).   The major differences  in fecundity  appeared to have
been due to differing pregnancy rates, however, rather than prenatal  mortality.  Impairment  of
male fertility by  lead rather  than lead-induced mutagenicity was thus likely  to have been the
primary toxic effect  observed.   Additionally,  it has been suggested by Leonard et al. (1973),
that effects  seen  following administration of  lead  acetate  in water may be  due  to resulting
acidity,  rather  than to  lead.   Also, Eyden et al.  (1978) found no decrease  in  fertility  of
male mice fed 0.1 percent lead acetate in the diet for 64 weeks.
     Several  animal  studies  have  found  lead-associated  damage  to  the testes or prostate,
generally at relatively high doses.  Golubovich et al. (1968) found a decrease in normal  sper-
matogonia in the testes of rats gavaged for 20 days with lead (2  mg/kg per day).  Desquamation
of the germinal  epithelium  of  the seminiferous tubules  was  also increased, as were degenera-
ting spermatogonia.  Hilderbrand et al. (1973) also noted testicular damage in male rats  given
oral lead (100  ug/day for 30 days).  Egorova  (cited  in Stb'fen,  1974) injected lead at a dose
of 2 pg/kg six times over a ten-day period and reported testicular damage.
     Ivanova-Chemishanska et al.  (1980)  investigated the effect  of lead on male rats adminis-
tered 0.0001 or  0.01 percent  solutions of lead acetate over a four-month period.   The authors
reported that changes  in enzymatic activity and in  levels of  disulfide and ATP were observed
in testicular homogenates.  No histopathological  changes in testicular tissue were found, but
the fertility index for treated males was decreased.   Offspring of those males exhibited  post-
partum  "failure  to thrive" and  stunted growth.   Such data suggest biological  effects due  to
chronic lead exposure  of the  male, but the  study  is difficult to evaluate due to limited in-
formation on the experimental  methods, particularly the dose levels actually received.
     In a more recent study of lead's effects on the male reproductive tract,  Chowdhury et al.
(1984) found testicular  atropy along with cellular  degeneration  in  rats exposed to lead ace-
tate in water  at 1 g/1  for 60 days.   Blood lead level at that exposure averaged 142.6 ug/dl.
At  a  lower  exposure  level  yielding  a blood  lead  concentration of  71.7  ug/dl,  seminiferous
tubular diameter was  singificantly  reduced,  as was  spermatid count.   No  significant changes
were seen at a blood lead level of 54.0 ug/dl.
                                          12-202

-------
     Non-rodent species  have  also  been investigated.  No  histopathological  changes  were seen
during an  examination  of the testes of rabbits  (Willems  et al., 1982).  Five males  per group
were dosed  subcutaneously  with up  to 0.5 mg/kg  lead acetate three times weekly for  14 weeks.
Blood lead  levels  at termination of treatment were  6.6  and 61.5 pg/dl  for  control  and high-
dose rabbits, respectively.
     Lead-related effects  on  spermatozoa  have also  been  reported.   For example, Stowe et al.
(1973) described the results  of a low-calcium and  phosphate diet containing 100 ppm lead (as
acetate) fed  to  dogs from 6  to  18  weeks  of age.  This dose resulted in a number of signs of
toxicity,  including  spermatogonia  with  hydropic degeneration.   In  a  study  by  Mai sin et al.
(1975), male  mice  received up to 1 percent  lead in the diet, and the percentage of abnormal
spermatozoa  increased  with increasing lead exposure.  Eyden et  al.  (1978) also fed 1 percent
lead  acetate in the diet to  male  mice.   By  the eighth  week,  abnormal  sperm had increased;
however, the  affected mice showed weight loss and other signs of general toxicity.  Thus, the
effect on spermatogenesis was  not indicative of  differential sensitivity of the gonad to lead.
     Krasovskii et al. (1979)  observed declines  in motility, duration  of motility, and osmotic
stability  of  sperm from rats  given 0.05 mg/kg  lead orally  for 20-30  days.   Damage to gonadal
blood vessels and  to Leydig  cells was  also  seen.   Rats treated for 6-12 months exhibited ab-
normal sperm  morphology  and decreased spermatogenesis.  In the report  of Will ems et al.  (1982)
described above, however,  no  effects on sperm count  or morphology were seen  in rabbits.
     Lead  acetate  effects on  sperm morphology  were also  tested in  mice given about one six-
teenth to  one half  an LD50 dose by i.p. injection  on five consecutive days  (Bruce and Heddle,
1979; Wyrobek and  Bruce, 1978;  Heddle and Bruce, 1977).   The two  lowest doses (apparently 100
and  250  mg/kg) resulted in  only a modest increase  in  morphologically abnormal  sperm 35 days
after treatment, but the 500  or 900  mg/kg  doses resulted  in up to  21 percent abnormal  sperm.
     That  lead could  directly affect developing sperm or their cellular precursors is made
more  plausible by the  data  of  Timm and Schulz (1966),  who  found lead  in the seminiferous
tubules  of rats  and in  their sperm.   The mechanisms for  lead's  effects on the male  gonad or
gamete are unknown,  although  Golubovich et  al.  (1968)  found altered  RNA  levels  in the  testes
of lead-exposed  rats.  They  suggested that testicular damage was  related to  diminished  riboso-
mal activity  and inhibition  of protein  synthesis.   As noted above,  Ivanova-Chemishanska et al.
(1980) observed  biochemical  changes  in  testes of lead-treated mice.   Nevertheless, such obser-
vations  are only initial  attempts  to determine a mechanism for  the observed effects  of lead.
A more  likely mechanism for  such  effects on the testes may be found in the  work of  Donovan et
al.  (1980), who  found that lead inhibited androgen  binding by the cytosolic  receptors  of mouse
prostate.   This could provide  a  mechanism  for  the observation of Khare et al. (1978), who
found  that  injection  of  lead acetate  into  the rat prostate resulted  in decreased prostatic
weight;  no such  changes  were seen  in  other  accessory sex glands or in the testes.
                                           12-203

-------
     Effects on  hormonal  production or on hormone receptors could also explain the results of
Maker et al.  (1975),  who observed a delay in testicular development and an increase in age of
first mating in male mice of two strains whose dams were given 0.08 percent lead (C57B1/6J) or
0.5  percent lead (Swiss-Webster  albino)  during pregnancy and  lactation.   The weanling males
were fed these same doses in their diets through 60 days of age.
     In attempts  to  further examine the possible  mechanisms  of effects on the male, Wiebe et
al.  (1982)  treated  rats  with lead acetate  injected  s.c.  from gestation day 9 every 3-4 days
throughout pregnancy and for the first 2-3 weeks of lactation.  Testes from the two- to three-
week-old male  offspring  of  treated mothers had  normal  weights  and seminiferous tubule diame-
ters, but yielded testicular homogenates with decreased ability  to convert progesterone to a
variety of  metabolites.   Such  results, in addition to  direct enzyme assays, showed decreased
activities  of  3a-,  3p-,  and 20crhydroxysteroid oxidoreductases  and of the 5crreductase and
             enzymes.  Receptor binding of FSH was also significantly reduced.   More recently,
Wiebe et  al.  (1983)  compared Sertoli cells isolated from prepubertal rats and cultured in the
presence  of either the acetate salts of lead or sodium (2.64 x 10   M).   After 24 hours, lead
exposure  was  associated  with a 10-20 percent decrease in FSH binding and in the production of
cyclic AMP; at  96 hours, the decrease was  75 percent.   Sixteen-day-old  rats were more sensi-
tive than those  20  days of  age and  exhibited a 97 percent decrease in FSH- induced cyclic AMP
by  144  hours  of lead  exposure.  The  ability  of Sertoli cells to  metabolize  progesterone and
their steroidogenic  response to  FSH was also inhibited by 48-hour lead exposure.  Activity of
cellular  3p-hydroxysteroid  dehydrogenase was  decreased after lead  exposure  in Sertoli  cells
and Tin vitro  in  the  presence of PbCl2 in the assay buffer.  These results support the concept
that  lead may  directly  affect testicular  enzymes or  may act  indirectly  by a  reduction  in
testicular binding of FSH and production of cyclic AMP.
     Another  potential mechanism underlying lead's effects on sperm involves its affinity for
sulfhydryl groups.   Mammalian  sperm  possess high concentrations of sulfhydryls believed to be
involved  in  the maintenance of motility and  maturation via regulation of  stability  in  sperm
heads and tails  (Bedford and Calvin, 1974; Calvin and Bedford, 1971).   It has also been found
that blockage of membrane thiols inhibits sperm maturation (Reyes et al., 1976).
12.6.2.1.2    Effects associated with exposure of females to lead.    Numerous   studies   have
focused on lead exposure effects  in females.   For example, effects of  lead on reproductive
functions  of  female  rats were studied by Hilderbrand et al.  (1973), using animals given lead
acetate orally at doses  of  5 or 100  ug  for 30 days.   Control rats of both sexes had the same
blood lead levels.   Blood lead levels of treated  females  were higher than those of similarly
treated males:   30 versus 19 ug/dl at the  low  dose,  and 53 versus 30 ug/dl at the high dose.
The females exhibited  irregular  estrous cycles at both doses.   When blood lead levels reached
50 ug/dl,  they developed ovarian follicular cysts, with reductions in numbers of corporalutea.
                                          12-204

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     In a subsequent study (Der et al.,  1974),  lead acetate (100 pg lead per day)  was  injected
subcutaneously  for  40 days  in weanling  female  rats.   Treated  rats  received a  low-protein
(4 percent) or  adequate-protein (20 percent) diet;  controls were given the same diets without
lead.   Females  on the  low-protein,  high-lead diet did not display vaginal opening during the
treatment  period  and their ovaries decreased  in  weight.   No estrous cycles were  observed in
animals from  either  low-protein group;  those of the adequate diet controls were normal,  while
those of the rats given adequate protein plus lead were irregular in length.   Endometrial pro-
liferation was  also  inhibited  by  lead treatment.  Blood  lead  levels were 23 ug/dl in the two
control groups, while values for the adequate-  and low-protein lead-treated groups were 61 and
1086 M9/dl, respectively.   The reports  of  Hilderbrand et al.  (1973)  and Der et  al.  (1974)
suggest that lead chronically administered in high doses can interfere with sexual development
in rats and the body burden of lead is greatly increased by protein deprivation.
     Maker  et  al.  (1975) noted  a  delay in  age at  first conception  in  female  mice of two
strains exposed  to  0.08  percent (C57B1/6J)  or 0.5 percent lead (Swiss-Webster) indirectly via
the maternal  diet (while  jji utero and  nursing) and  directly  up  to  60 days of  age.   These
females were  retarded in  growth  and  tended to conceive only after reaching weights  approxi-
mating those  at which untreated mice normally  first  conceive.   Litters from females that had
themselves been  developmentally exposed to  at least 0.5 percent lead had  lower survival  rates
and retarded  development.  More recently, Grant et al. (1980) reported delayed vaginal opening
in  rats whose mothers were given 25, 50, or 250 ppm lead (as  lead acetate) in their drinking
water  during  gestation  and  lactation followed by equivalent exposure  of  the offspring after
weaning.   The vaginal opening  delays in the  25-ppm females  occurred in  the  absence of any
growth  retardation  or other  developmental  delays and were  associated  with  median blood lead
levels of  18-29 ug/dl.
     Although  most  animal  studies have used rodents, Vermande-Van  Eck and Meigs (1960) admin-
istered  lead  chloride   intravenously to female  rhesus monkeys.   The monkeys were  given 10
ing/week for  four weeks  and 20 mg/week  for  the next seven months.   Lead treatment resulted in
cessation  of  menstruation,  loss  of  color  of  the  "sex  skin" (presumably  due  to  decreased
estrogen  production),  and pathological  changes  in the ovaries.  One to five months after  lead
treatment  ceased, menstrual  periods  resumed,  the  sex skin returned to  a normal color, and the
ovaries  regained their  normal  appearance.    Thus,  there was  an  apparent  reversal  of  these
effects  on  female  reproductive   functions,   although  there  were  no confirmatory  tests of
fertility.
     The  above studies  indicate  that pre-  and/or postnatal  exposure of female  animals to lead
can affect  pubertal progression  and  hypothalamic-pituitary-ovarian-uterine functions.  The
observations  of delayed vaginal  opening may reflect  delayed ovarian estrogen secretion  due to
                                           12-205

-------
toxicity  to  the  ovary,  hypothalamus,  or pituitary.   One  study has demonstrated  decreased
levels of  circulating  follicle-stimulating  hormone (Petrusz et al.,  1979), and others discus-
sed previously  have shown  lead-induced  ovarian atrophy (Stowe and Goyer,  1971;  Vermande-Van
Eck and Meigs,  1960),  again suggesting toxicity involving the hypothalamic-pituitary-ovarian-
endometrial axis.
12.6.2.2   Effects of Lead on the Offspring.   This section  discusses  developmental  studies  of
animals whose parents  (one  or  both) were exposed  to  lead.   Possible male-mediated effects  as
well as effects  of  exposure during gestation are reviewed.   Results  obtained for offspring  of
females given  lead  following  implantation  or throughout pregnancy are  summarized  in Tables
12-14 and 12-15.
12.6.2.2.1  Male-mediated effects.  A  few studies have focused on male-mediated  lead effects
on  the  offspring and  have suggested that paternally transmitted effects of lead may cause re-
ductions  in litter size, offspring weight, and survival rate.
     Cole  and  Bachhuber (1915), using rabbits,  were  the first to report  paternal  effects  of
lead intoxication.  In their study, the litters of dams sired by lead-intoxicated male rabbits
were smaller than those sired by controls.  Weller (1915) similarly demonstrated reduced birth
weights and survival among offspring of lead-exposed male guinea pigs.
     Offspring  of  lead-treated males  from  the  Ivanova-Chemishanska  et al.  (1980)  study de-
scribed above were affected in a variety of ways, e.g., they exhibited "failure to thrive" and
lower weights than  did control progeny at one  and three weeks postpartum.  These results are
difficult to interpret, however, without more specific information on the experimental methods
and dosing procedures.
12.6.2.2.2  Results of lead exposure of both  parents.   Only a  few studies  have  assessed the
effects  of lead  exposure  of  both  parents  on  reproduction.   Schroeder and  Mitchener (1971)
found a  reduction in  the number of offspring of rats and mice given drinking water containing
25  ppm  lead.  According  to  the data of Schroeder et  al.  (1970), however, animals in the 1971
study may have  been chromium-deficient,  and the Schroeder and Mitchener (1971) results are in
marked contrast  to those of an earlier study by Morris et al. (1938), who reported no signifi-
cant reduction in weaning percentage among offspring of rats fed 512 ppm lead.
     In  another study,  Stowe  and Goyer  (1971) assessed the  relative paternal  and maternal
effects of  lead as  measured by effects on  the progeny of  lead-intoxicated rats.  Female rats
fed diets with or without 1 percent lead were mated with normal males.  The pregnant rats were
continued on their respective  rations with or without lead  throughout gestation and lactation.
Offspring  of  these matings,  the Fj generation,  were fed the rations of  their dams and were
mated in  combinations  as follows:  control female  to control  male (CF-CM), control female to
lead-intoxicated  male  (CF-PbM),  lead-intoxicated  female to control  male  (PbF-CM),  and  lead-

                                          12-206

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TABLE 12-14.   EFFECTS OF  PRENATAL
                           STUDIES
EXPOSURE TO LEAD ON THE OFFSPRING OF LABORATORY AND DOMESTIC ANIMALS:
USING ORAL OR INHALATION ROUTES OF EXPOSURE
Treatment
Species Test agent Dose and node
Rat Lead acetate 512 ppm in diet
10,000 pp» in diet
39 mg/kg/day, po
390 ag/kg/day, po
255-478 «g/kg/day in
water
31.9-319 ppM in water
50*250 ppn in water
25 ppn in water
0.5-5 ppa in water
5 or 50 ppn in water
£ 31.9-47.8 •g/kg/day, po
^ 63.7 «g/kg/day, po
^ 150 ng/kg/day, po
500 ppn in water
5 ppm in water
5-500 ppm in water
Tetraethyl lead 1.6-3.2 «g/kg/day, po
0.064 ng/kg/day, po
0.64 ng/kg/day, po
6.4 mg/kg/day, po
Tetranethyl lead 10-28.7 mg/kg/day, po
Trinethyl lead 3.6-7.2 ng/kg/day, po
chloride
Lead nitrate 1 pp* in water
10 ppa in water
Lead (aerosol) 1 or 3 mg/m3, inhaled
10 ag/H3, inhaled

Tiningc
all
all
6-16
6-8
all, LAC
all
all, LAC
all, LAC
all, LAC
all, LAC
all
all
6-18
1-18 or 1-21
1-18 or 1-21
all, LAC
9-11 or 12-14
6-16
6-16
6-8
9-11 or 12-14
9-11 or 12-14
all
all
1-21
1-21
Effect on the offspring3
Mortality Fetotoxicity Malformation Reference
? Morris et al. (1938)
* + ? Stowe and Goyer (1971)
Kennedy et al. (1975)
? +d ? Murray et al. (1978)
±e + - Oilts and Ahokas (1979, 1980)
* - Kiwnel et al. (1980)
±
+ + - Herman et al. (1981)
Miller et al. (1982)
* - - Wardell et al. (1982)
+ - Hayashi (1983a)
+ - Hayashi (1983b)
+ - Victery et al. (1983)
± + - McClain and Becker (1972)
Kennedy et al. (1975)
± + - McClain and Becker (1972)
+
? Hubenmnt et al. (1976)
? -* ? Prigge and Greve (1977)

-------
                                                                    TABLE 12-14.  (continued)
o
oo
Species
House








Sheep
Treatment
Test agent Dose and mode
Lead acetate 3,185 ppm in diet
780-1,593 ppm in diet
3,135 ppn in diet
1,593-6,370 ppm in diet
1,595-3,185 ppm in diet
39 *g/kg/day, po
390 mg/kg/day, po
0.1-1.0 g/1 in water
637-3,185 ppm in diet
1,593 ppm in diet
3,185 ppn in diet
1,250 ppm in diet
3,185 ppm in diet
1,250 ppm in diet
2,500-5,000 ppm
in diet
1,250 ppm in diet
1,000 ppm in diet
Tetraethyl lead 0.06 mg/kg/day, po
0.64 mg/kg/day, po
6.4 mg/kg/day, po
Lead powder 0. 5- 16 -mg/kg/day, in
diet1

Timingc
1-7
1-16,17, or 18
1-16,17, or 18
1-15,16, or 17
7-16,17, or 18
5-15
5-7
all
1-18
1-16,17, or 18
1-16,17, or 18
all
1-16,17, or 18
all
all
all
all, LAC
6-16
6-16
6-8
all
Effect on the offspring8
Mortality Fetotoxicity Malformation
+ ± N/A
; :tf,j ;
7 <-'( 7
? + ?
+ + -
7 7
+ ? ?
: : :
+ + -
+ ?
Reference
Jacquet (1977)
Jacquet et al. (1977b)
Gerber and Maes (1978)
Gerber et al . (1978)
Kennedy et al . (1975)
Leonard et al. (1973)
Maisin et al. (1975)
Jacquet et al. (1975)
Jacquet (1976)
Talcott and Koller (1983)
Kennedy et al. (1975)
Shama and Buck (1976)
    + =  present; - = effect not  seen; ± = ambiguous effect; ? = effect not examined  or  insufficient  data.
    Oose as  elemental  lead; po = per os (gavage).
    cSpecific gestation days when exposed; LAC =  also during lactation.
    Decreased numbers  of dendritic  spines and malformed spines at day 30 postpartun.
    Litter size values for high-dose group  suggestive of  an effect.
    ALA-D activity was decreased.
    %ree tissue porphyrins increased in kidneys.
    Henatocrit was decreased.
    Vetal porphyrins were increased, except in the low-dose fetuses assayed on gestation day 18.
    •'Decreased heme and fetal weight.
    Incorporation of Fe into heme decreased, and growth was retarded.
    Decreased placental blood flow.

-------
TABLE 12-15.  EFFECTS  OF  PRENATAL LEAD EXPOSURE ON OFFSPRING OF LABORATORY ANIMALS:
         RESULTS OF STUDIES EMPLOYING ADMINISTRATION OF LEAD BY INJECTION
Species
Rat



_
i
no
a
•£>



House

Treatment
Test agent Dose and node
Lead acetate 15.9 ngAg, ip
Lead nitrate 31.3 mg/kg, iv
31.3 mg/kg, iv
31.3 ng/kg, iv
3.13 mg/kg, iv
15.6 mg/kg, iv
15.6 ng/kg, iv
unknown, iv

31.3 mg/kg, iv
15.6 mg/kg, iv
5 ng/kg, iv
25 mg/kg, iv
Lead chloride 7.5 ng/kg^
75 Kg/kg,
Tri nethyl lead 20.2 mg/kg, iv
chloride 23.8 mg/kg, iv
Lead acetate 9.56-22.3 mg/kg, ip
9.56 mg/kg, ip
22.3 »g/kg, ip
22.3 mg/kg, ip
Lead chloride 29.8 «g/kg, iv
29.8 mg/kg, iv

Timingc
9
8
9 or 16
10-14,
15,17
9 or 15
9
15
8 or 9

17
17
9 or 15
9 or 15
9
9
12
9,10,13, or 15
8
9
9
10 or 12
3 or 4
6
Effect on the offspring3
Mortality Fetotoxicity Malformation Reference
+ + + Zegarska et al. (1974)
+ + McClain and Becker (1975)
Hackett et al. (1978, 1979)
+ 7 7
+ ? + Coro Antich and Aaoedo Non
(1980)
+ - Minsker et al. (1982)
- e Hackett et al. (1982a,b)
± - - Mclellan et al. (1974)
+9 + I
+ + Jacquet and Gerber (1979)
+ *
+ + +
+ ? ? Wide and Nilsson (1977)
+ N/A N/A

-------
                                                                 TABLE 12-15.   (continued)
Species
Hamster


*— •
IV)
i
IV)
o
Test agent
Lead acetate
Lead acetate or
chloride
Lead nitrate


Treatment
Dose and Mode
31.9 ag/kg, iv
31.9 or 37.3 «g/kg, iv
31.3 «g/kg. iv
15.6-31.3 mg/kg, iv
31.3 ng/kg, iv
31.3 ag/kg. iv

Tiihngc
8
8
7, 8. or 9
8 or 9
8
8
Effect on the offspring3
Mortality Fetotoxicity Malformation Reference
+ ? + Fen« (1969)
? ? + Fem and Carpenter (1967)
? ? + Fem and Carpenter (1967)
•f ? + Fem and Fern (1971)
+ + + Carpenter and Fen (1977)
+ +h + Gale (1978)
a+ = effect present; - = effect not seen; ± = aabiguous effect; ? = effect not examined or insufficient data.
 Dose as elemental lead; ip = intraperitoneally; iv = intravenously.
cSpecific gestation days when exposed.
''with the exception of day 17.
eHo fetuses survived to be examined for malfon»ation.
 No dosage route specified.
°0nly after day 10 treatment.
"Delayed ossification (fetal weights not given).

-------
intoxicated female to lead-intoxicated male (PbF-PbM).   The results of this study are shown in
Table 12-16.
     The paternal effects  of  lead included reductions  of 15 percent in the number of pups per
litter, 12 percent  in  mean pup birth weight, and 18 percent in pup survival  rate.   The mater-
nal effects of  lead included  reductions of 26 percent  in litter size, 19 percent in pup birth
weight, and 41 percent in pup  survival.   The combined male and female effects of lead toxicity
resulted in reductions of 35 percent in the number of pups per litter, 29 percent in pup birth
weight, and 67  percent in pup survival  to weaning.   Stowe and Goyer classified the effects of
lead  upon  reproduction as  gametotoxic,  intrauterine,  and  extrauterine.   The  gametotoxic ef-
fects  of lead  seemed to be irreversible and  had additive male and female components.  Intra-
uterine effects  were presumed to be due to lead uptake by the conceptus, plus gametotoxic ef-
fects.  The extrauterine  effects were due to  the  passage of lead from the dam to the nursing
pups,  adding to  the  gametotoxic and intrauterine effects.
      Leonard et  al.  (1973), however, found no effect on the reproductive performance of groups
of  20 pairs  of mice given  lead  in  their drinking water over a nine-month period.  Lead doses
ranged from 0.1 to  1.0 g/1.  A total amount of 31 g/kg was ingested at the high dose, equiva-
lent  to ingestion of 2.2  kg lead by a 70-kg man over the same time period.
      More recently,  rats  from mothers that were exposed to  lead at 5 or 50 ppm or to  lead plus
cadmium at  concentrations of  5 ppm  Pb  + 0.1 ppm Cd or  50 ppm Pb +  5  ppm Cd in the drinking
water during  gestation and lactation were themselves continued on the same treatments (Herman
et  al.,  1981).   All individuals were treated  during mating, with the mated females also being
treated during  gestation and  given a teratological examination at day 20.  Other females were
allowed to  litter and treatment was continued through postpartum day 21.  Treatment with lead
or  lead plus cadmium appeared to cause preimplantation loss.   In the  groups allowed to litter,
maternal weight gain,  litter  size, and  offspring  survival and weight were all  said  to be re-
duced in  both lead  groups  and more  severely in the Pb  plus  Cd groups.   Eye opening was also
delayed  in  all  groups.  The  value  of  these results is  not clear,  however,  as  no  statistical
analysis was mentioned.
12.6.2.2.3   Lead effects on implantation and early development.   Numerous studies  have been
performed  to  elucidate mechanisms  by  which  lead causes  prenatal  death.   They suggest two
mechanisms  of action for  lead,  one  on  implantation and the other  (mainly at higher  doses) on
fetal development.   The latter is discussed  primarily  in  Section 12.6.2.2.4.5.
      Mai sin  et al.   (1975)  exposed  female  mice to dietary  lead for  18 days after  mating; the
number of both pregnancies and  surviving embryos decreased.   Similarly, exposure  of  female
mice  to lead via their diet  (0.125-1.0  percent)  from  mating  to 16-18 days afterward (Jacquet,
1976; Jacquet et al.,  1975)  resulted  in the  following:   decreased  incidence of pregnancy and
number of corpora  lutea;  increased  number of embryos  dying after  implantation at the highest
dosages;  decreased body weights  of  surviving fetuses;  and fatalities among treated dams at the
                                           12-211

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              TABLE 12-16.  REPRODUCTIVE PERFORMANCE OF F!  LEAD-INTOXICATED  RATS  (MEANS ± STANDARD ERRORS)
ro
t
ro
i—•
TN3
Parameter
Litters observed
Pups per litter
Pup birth weight, g
Weaned rats per litter
Survival rate, %
Litter birth weight, a.
Dam breeding weight
Litter birth weight, ^
Dam whelping weight
Gestational qain,
Pups per litter *•
Nonfetal gestational
gain per fetus, g




CF-CM
22
11.90
6.74
9.84
89.80
28.04
19.09
11.54
3.93
±
±
±
±
±
±
±
±
0.40
0.15
0.50
3.20
1.30
0.80
0.60
0.38
10.
5.
7.
73.
22.
15.
11.
4.

Type of
CF-PbM
24
10 ±
92 ±
04 ±
70 ±
30 ±
97 ±
20 ±
83 ±

0.50
0.13C
0.77C
7.90
0.90C
0.58C
0.74
0.47
mating

PbF-CM
36
8.78 ±
5.44 ±
5.41 ±
52.60 ±
19.35 ±
14.28 ±
11.17 ±
4.15 ±

0.30b
0.13c'd
0.74C'd
7.20
1.00C
0.66C
0.54
0.42



PbF-PbM

7.75
4.80
2.72
30.00
15.38
11.58
12.34
3.96
16
± 0.50C
± 0.19°
± 0.70C
± 8.20C
± 1.10C
± 0.78C
±1.24
± 0.46


,d,e
,d,e
,d,f
,d,f
,d,f


         aCF = control female; CM = control male; PbM = lead-treated male;  PbF = lead-treated female.

         Significantly (p <0.05) less than mean for CF-CM.

         Significantly (p <0.01) less than mean for CF-CM.

         Significantly (p <0.01) less than mean for CF-PbM.

         Significantly (p <0.01) less than mean for PbF-CM.

          Significantly (p <0.05) less than mean for PbF-CM.


         Source:  Stowe and Goyer (1971).

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high dose.  Jacquet and co-workers described effects of maternal dietary lead exposure on pre-
implantation mouse embryos (Jacquet, 1976; Jacquet et a!., 1976).   They found lead in the diet
to be associated with retardation of cleavage in embryos, failure of trophoblastic giant cells
to differentiate, and absence of a uterine decidual reaction.   Maisin et al.  (1978) also found
delayed cleavage  in  embryos  of mice fed  lead  acetate  prior to mating and up to 7 days after-
wards.
     Giavini et al. (1980) further confirmed the ability of lead to affect the preimplantation
embryo  in  studies  of  rats  transplacentally exposed  to lead  nitrate,-and  Wide  and  Nilsson
(1977,  1979)  reported  that  inorganic  lead  had  similar effects on mice.  Jacquet (1978) was
able  to force  implantation in that species  by  use of high doses  of  progesterone,  while Wide
(1980)  determined that administration of  estradiol-17p and  progesterone could  reverse the
effects of  lead  on implantation.   Wide suggested  that the  lead-induced implantation blockage
was mediated by a decrease in endometrial responsiveness to both sex steroids.  Jacquet (1976)
and Jacquet et al. (1977b) had attributed lead-induced prevention of implantation in the mouse
to  a lack  of  endogenous  progesterone  alone,  stating  that estrogen  levels  were unaffected.
Later,  however,  Jacquet et al. (1977a) stated  that estrogen  levels also decreased, a finding
not supported by Wide and Wide (1980).  The  latter  authors  did  find a  lead-induced increase in
uterine  estradiol receptors,  but  no  change  in  binding  affinities.  Although  sex steroids
appear  to be  involved  in  lead's  effects  on implantation in rodents,  the precise mechanism is
not clear.
      In order  to examine lead's  effects  early  in gestation,  Wide and Nilsson (1977) examined
embryos from  untreated  mice and  from mothers  given 1 mg lead  chloride on days  3, 4, or 6 of
pregnancy.  Embryonic mortality  was greater in  lead-treated  litters; in the day-6 group some
abnormal  embryos  were observed by  day  8.   In  a later  experiment, Wide (1978) removed blasto-
cysts  from lead-treated  mice.   She found  that they  attached  and grew normally during  three
days  of jn vitro culture.  Other  blastocysts from untreated  mothers were  cultured in  media
containing  lead,  and a dose-dependent decrease in the number  of normally developing embryos
was  seen.   Wide (1983) then transplanted blastocysts  from mice treated with an  implantation-
inhibiting  lead  dose and found that  they implanted and developed  normally  in foster mothers.
      In a  more  recent  study, Molls  et  al.  (1983) exposed two-cell  mouse  embryos to 0.1 or
1.0  ^g lead  chloride  per ml  of culture  medium.   By  64  hours of incubation, both  treatment
levels  had  resulted  in  decreased  cell proliferation.   Cell  death was  also  seen  in morula stage
lead-treated  embryos.   Exposure  to x-rays  one  hour after the start of incubation had an addi-
tional  (but not  synergistic)  effect.
      A  study employing domestic sheep  was reported  by  Sharma and Buck (1976), who  fed lead
powder  to  pregnant ewes  throughout gestation.   Levels in  the  diet were varied from 0.5 to 16
mg/kg per  day in  an  effort to keep blood lead levels near 40 ug/dl (actual  levels ranged from
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30 to  70 ug/dl).  Such  treatment resulted  in  a greatly decreased lambing percentage  but no
gross  malformations.   However,  only 11  lead-treated  and  9  control  subjects were  studied.
12.6.2.2.4  Teratogenicity and prenatal  toxicity of lead in animals.
     12.6.2.2.4.1  High dose effects on the conceptus.  Teratogenic effects  refer to physical
defects (malformations) in the developing offspring.   Prenatal toxicity (embryotoxicity, feto-
toxicity) includes premature  birth,  prenatal death,  stunting,  histopathological  effects,  and
transient biochemical or  physiological  changes.   Behavioral teratogenicity,  consisting of be-
havioral alterations  or  functional  (e.g.,  motor, sensory)  deficits  resulting from  in uterq
exposure, is considered in Section 12.4.3 of this chapter.
     Teratogenicity of  lead,  at  high  exposure  levels,  has been demonstrated  in rodents  and
birds, with some results  suggesting a species-related specificity of certain  gross teratogenic
effects.   Perm and  Carpenter  (1967),  as well  as Perm and  Perm (1971), reported  increased
embryonic resorption  and  malformation  rates when various lead salts were administered i.v. to
pregnant hamsters.  Teratogenic  effects were largely restricted to the tail  region,  including
malformations  of sacral   and  caudal  vertebrae  resulting  in  absent  or stunted  tails.   Gale
(1978)  found  the same effects,  plus hydrocephalus,  among six strains of hamsters  and noted
differences in  susceptibility,  suggesting a genetic component in lead-induced teratogenicity.
     Zegarska et al.  (1974) performed a study with rats injected with lead acetate at mid-ges-
tation.  They  reported embryonic mortality and malformations.  McClain and Becker (1975) sub-
sequently administered lead nitrate  i.v.  to rats  on  one  of days 8-17 of gestation,  producing
malformations  and  embryo- and  fetotoxicity.   Hackett  et  al.  (1978,  1982a,b)  also  gave lead
i.v.   to rats and found malformations and high incidences of  prenatal  mortality. Minsker et
al.  (1982)  gave lead  i.v.  to dams on day 17 of gestation and observed decreased  birth weights
as well as decreased weight and survival by postpartum day 7.
     In another study, Miller et al. (1982)  used oral  doses of  lead  acetate  up  to  100 mg/kg
given  daily  to rats  before breeding and  throughout  pregnancy and found fetal stunting at the
high  dose,  but no other  effects.  Maternal blood  lead values ranged from 80 to 92 ug/dl prior
to mating  and  from  53 to  92 ug/dl during pregnancy.  Pretreatment  and control blood lead
levels averaged 6-10 ug/dl.  Also, Warden et al.  (1982) gavaged  rats daily with  lead doses of
up to  150  mg/kg from gestation  day  6-18  and observed decreased prenatal survival at the high
dose,  but no malformations.
     Perm (1969) reported that teratogenic effects of i.v.  lead in hamsters are potentiated in
the  presence  of cadmium,  leading to severe  caudal dysplasia.   This finding was  duplicated by
Hilbelink (1980).  In addition to caudal malformations, lead appears to influence the morphol-
ogy  of the  developing brain.   Por example, Murray et  al.  (1978)  described  a significant
decrease in  number  of dendritic spines and  observed a variety of morphological  abnormalities
of such  spines in the parietal cortex  of 30-day-old  rat pups exposed to lead during gestation
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and nursing, during  the  postweam'ng period only, or during both periods.   Morphometric analy-
sis of rats  transplacentally  exposed to lead indicated  that  cellular organelles were altered
as  a  function  of dose  and  stage  of development  at  exposure  (Klein  et al.,  1978).   These
results indicate  that  morphologically apparent  effects of lead on the brain could be produced
by  exposure  during pregnancy  alone,  a question  not  addressed by Murray et  al.  (1978).   See
Section 12.4.3  for a discussion of other  studies  relating lead exposure to morphological  and
functional alterations in the CMS of developing animals.
     12.6.2.2.4.2  Low-dose effects  on the conceptus.   There  is a paucity  of information  re-
garding the  teratogenicity and  developmental  toxicity  of  prolonged  low-level  lead exposure.
Kimmel et al. (1980)  exposed  female rats chronically to lead acetate via drinking water (0.5,
5,  50,  and  250  ppm) from weaning  through  mating, gestation,  and  lactation.   They observed a
decrease  in  fetal  body length of female offspring at  the high dose, and the female offspring
from the  50  and 250 ppm groups weighed less at weaning  and showed delays in physical develop-
ment.   Maternal  toxicity was  evident in the rats  given  25 ppm or higher doses, corresponding
to  blood  lead  levels  of 20  ug/dl  or higher.   Reiter  et al.  (1975) observed  delays  in  the
development of the nervous system in offspring exposed to 50 ppm lead throughout gestation and
lactation.  Whether  these  delays in development  resulted  from a direct effect of lead on the
nervous system of the pups or reflect secondary changes  (resulting from malnutrition, hormonal
imbalance, etc.)  is  not  clear.  Whatever  the mechanisms involved, these studies suggest that
low-level, chronic exposure to lead may induce postnatal developmental delays.
     12.6.2.2.4.3  Prenatal effects  of  organolead compounds.   In an  initial  study of the ef-
fects of  organolead  compounds in animals, McClain and Becker (1972) treated rats orally with
7.5-30 mg/kg tetraethyl   lead,  40-160 mg/kg  tetramethyl lead,  or 15-38  mg/kg trimethyl lead
chloride, given  in three divided doses on  gestation days 9-11 or 12-14.  The  last compound was
also  given   intravenously  at  doses of  20-40  mg/kg on  one of  days  8-15  of pregnancy.   The
highest dose of  each agent resulted  in maternal death, while  lower doses caused  maternal toxi-
city.  At all  dose levels, fetuses  from  dams  given multiple treatment weighed  less than con-
trols.  Single  treatments at the highest  doses tended to  have  similar effects.   In  some cases
delayed ossification was observed.   In addition,  direct intra-amniotic injection  of trimethyl
lead chloride at levels  up to  100 ug per fetus caused  increasing fetal mortality.
     Kennedy  et al.  (1975) administered tetraethyl lead by gavage to mice  and rats  during the
period of organogenesis  at dose  levels  up  to 10 mg/kg.   Maternal toxicity,  prenatal  mortality,
and developmental  retardation  were  noted at the  highest  doses  in both species, although mater-
nal treatment was discontinued after only three days due  to  excessive toxicity.   In a  subse-
quent study  involving  alkyl lead, Odenbro  and Kihlstrom  (1977)  treated  female mice orally with
triethyl  lead at doses  of up  to 3.0 rag/kg per  day on days 3-5 following mating.   The highest
treatment levels resulted  in  decreased  pregnancy rates,  while at 1.5  mg/kg, lower implantation
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rates were  seen.   In order to elucidate the mechanism  of implantation failure in organolead-
intoxicated mice,  Odenbro  et al.  (1982) measured plasma  sex  steroid levels in mice five days
after  mating.   Levels of  both estradiol  and  progesterone,  but  not estrone, were  decreased
following intraperitoneal  triethyl  lead chloride on  days three and four of  gestation.   Such
results suggest  a hormonal mechanism  for  blockage  of implantation, a  finding  also suggested
for  inorganic  lead  (Wide, 1980;  Jacquet et  al.,  1977a).   In an  attempt to elucidate  the
mechanism by which organolead compounds  decrease  fetal growth, Kihlstrom  and  Odenbro  (1983)
treated guinea pigs  with  i.p.  triethyl lead  chloride.  They observed reduced placental  trans-
fer  of  alpha-amino isobutyrate following  doses of 2.5 mg/kg,  but no effect was  seen  at  1.0
rag/kg.
     12.6.2.2.4.4  Effects of lead on fetal phy"^^Y and metabolism.   Biochemical indicators
of developmental  toxicity have been the subject of a number of investigations, as  possible in-
dicators of subtle prenatal  effects.   Hubermont et al. (1976)  exposed female rats to lead in
drinking water before mating,  during pregnancy, and  after delivery.   In the highest exposure
group (10 ppm), maternal  and  offspring blood lead values were  elevated and approached 68 and
42 ug/dl,  respectively.   Inhibition of ALA-D and elevation of free tissue porphyrins were also
noted in the newborns.   Maternal  diets containing up to 0.5 percent lead were associated with
increased fetal porphyrins and decreased ALA-D activity by Jacquet et al. (1977a).  Fetuses in
the high-dose  group  had  decreased weights, but no data were presented on maternal weight gain
or food consumption (which could have influenced fetal weight).
     Fetal  effects were  also investigated by Hayashi (1983a,b), who reported that lead levels
as low  as 5 ppm in the  drinking  water of rats for the first 18-21 days of pregnancy resulted
in decreased   ALA-D  activity  in  the  fetal  erythrocytes.  Fetal  hepatic ALA-D  activity  was
increased in the  lead-treated groups, while hematocrit and hemoglobin concentrations were de-
creased by  day 21.  Fetal blood  leads  were  27 ± 16  and  19 ± 10 ug/dl  in  the  18- and 21-day
groups, respectively.
     In  the  only  inhalation exposure  study  (Prigge  and Greve,  1977),  rats  were  exposed
throughout gestation to an aerosol containing 1, 3,  or 10 mg Pb/m3 or to a combination of 3 mg
Pb/m3 and 500  ppm  carbon monoxide (CO).  Both maternal and fetal ALA-D activities were strong-
ly inhibited by lead exposure  in a dose-related manner.  In the presence of lead plus CO, how-
ever,  fetal  (but  not maternal) ALA-D  activity  was  higher than in the group given lead alone,
possibly due to  the increase  in  total  ALA-D  seen  in the CO-plus-lead treated fetuses.  Fetal
body weight and  hematocrit were decreased in  the high-dose  lead group, while maternal values
were  unchanged,  thus suggesting  that  the  fetuses  were more  sensitive  to lead's  effects than
were  the  mothers.  Granahan  and  Huber (1978)  also  reported  decreased  hematocrit, as well as
reduced  hemoglobin levels,  in fetal  rats from lead-intoxicated  dams  (1000 ppm  in the diet
throughout  gestation).
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     Gerber and Maes (1978) fed pregnant mice diets containing up to one percent lead from day
7 to  18 of  pregnancy  and determined  levels of  heme  synthesis.   Incorporation of  iron  into
fetal   heme was  inhibited,  but glycine  incorporation  into heme  and protein was  unaffected.
Gerber et  al.  (1978)  also found that dietary  lead given late in gestation resulted in dimin-
ished  placental  blood flow  but did not  decrease uptake  of  a  non-metabolizable  amino acid,
alpha-ami no  isobutyrate.   The  authors  could not  determine whether lead-induced  fetal  growth
retardation  was  due to  placental  insufficiency  or  to the previously  described  reduction in
heme synthesis (Gerber and Maes, 1978).   They did  not mention the possibility that the treated
mothers may have reduced their  food consumption, resulting in a reduced nutrient supply to the
fetus, regardless of fetal ability to absorb nutrients.
     In  another  study where  evidence  of  physiological  changes was seen  at  low  lead levels,
rats were  given  0,  5,  25, 100, or  500  ppm  lead  in  their  drinking water throughout gestation
and lactation  (Victery et  al., 1983).   Their  offspring were tested at one  month of age and
plasma renin activity  was found to be  elevated at all dose  levels, while renal renin concen-
trations  were  elevated  at  the two highest doses.   The  increases in plasma  angiotensin II
(All)  levels found  in the offspring of  rats treated with 100 and  500 ppm lead were partially
inhibited  when the  one-month-old  pups were  anesthetized and  subjected to a surgical procedure
(laparotomy) prior  to sampling.   Such  results  suggest  that exposure  to  relatively low lead
levels  during  development and  via nursing  may enhance basal  renin secretion  in young rats,
while at least at higher  levels (the two low-dose  groups were not tested for All), such treat-
ment tended  to inhibit the response to renin-releasing conditions.
     More  recently,  Wardell  et al.  (1982)  exposed rat fetuses 21} utero  to  lead by gavaging
their  pregnant  mothers   with  150  mg/kg  on  gestation days 6-18.   On  day 19,  fetal  limb
cartilage  was tested for  ability to synthesize  protein, DNA,  and proteoglycans, but no adverse
effects  were seen.   Also, Talcott and  Koller  (1983) found no effect  on  the  immune system of
the  offspring of  mice  exposed during  gestation  to  1000 ppm  dietary lead with or without
Aroclor  1254.
     12.6.2.2.4.5   Possible mechanisms of lead-induced teratogenesis.   The  reasons  for  the
localization of  many of  the  gross teratogenic  effects of  lead are  unknown at this time.  Perm
and Perm (1971)  have suggested that  the  observed specificity could be explained  by an inter-
ference  with specific enzymatic  events.   Lead  alters mitochondrial function and enhances or
inhibits enzymes (see Section 12.2.1);  any or all  such effects could ultimately interfere with
normal development.  Similarly, inhibition of ALA production  has been  suggested as a mechanism
of  teratogenesis by Cole  and Cole (1976), while  Danielsson  et  al. (1983) have proposed  that
lead's  teratogenic  effects may be based  in  part  on a functional  oxygen  deficiency  in certain
tissues  due  to an interference  with  fetal  heme  production.
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      In  an attempt to  study  the mechanics of lead  induction  of sacral-tail region malforma-
tions, Carpenter  and  Perm (1977) examined hamster embryos treated at mid-gestation during the
critical  stage  for response to  teratogens in this species.  The initial effects were edema of
the  tail  region of embryos  30 hours after maternal  exposure,  followed  by blisters and hema-
tomas.  These  events  disrupted  normal caudal development,  presumably by mechanical displace-
ment.  The end results  seen in  surviving fetuses were missing,  stunted, or malformed tails and
anomalies of the lower  spinal  cord and adjacent vertebrae.
      12.6.2.2.4.6    Maternal  factors in lead-induced teratogenesis and fetotoxicity.    Nutri-
tional factors  may also have  a  bearing  on the prenatal toxicity of  lead.   Jacquet and Gerber
(1979)  reported  increased  mortality  and  defects  in  fetuses  of mice  given intraperitoneal
injections  of  lead  while  consuming a calcium-deficient  diet during gestation.   In several
treatment  groups,  lead-treated calcium-deficient mothers had  low  blood  calcium  levels, while
controls on the same diet had  normal values.  It is not certain how meaningful these data are,
however,  as  there  was no clear  dose-response relationship within diet groups.  In fact, fetal
weights were  said  to  be significantly higher in two of the lead-treated groups (on the normal
diet)  than  in  the untreated controls.  Another problem with the study was that litter numbers
were  smal1.
      In a  later  study,  Carpenter (1982) reported  greater  prenatal  mortality and incidence of
malformations in  fetal  hamsters from mothers given  0.05  or 0.1 percent lead acetate in their
drinking water if the mothers were also on diets deficient in either calcium or iron.   Numbers
of  litters  per  group  were small, however, and the two lead dose groups were combined when the
data were averaged, making the  results difficult to interpret.
     Another  study on interactions  of lead with  other  elements was done  by Dilts  and Ahokas
(1979), who  exposed  rats to lead in their drinking water throughout gestation.   Controls were
pair-fed  or  fed  ad libitum.   Lead treatment was said to result in decreased fetal weight, and
dietary zinc  supplementation  was  claimed  to be  associated with a  protective  effect against
fetal  stunting.   The  data  as  presented do  not allow  the  differentiation  of effects  due to
maternal stress (e.g., decreased food consumption) from direct effects on the fetus.  In addi-
tion,  litter numbers  were small, and some of  the  data  were confusing.   For example,  a lead-
treated  and a  pair-fed group  had  very similar  litter sizes  and  total   litter  weights,  but
rather dissimilar average fetal weights; also, dividing live litter weight by live litter size
does  not  give  the  authors'  values for average  fetal  weight.   Finally, no data  were  given on
maternal  or  fetal  lead  or zinc  levels.   In a further report on apparently the same animals as
above, Dilts and Ahokas (1980)  found that lead  inhibited  cell division and decreased protein
contents of the fetal  placentas, eviscerated carcasses,  and livers.   Such lead-related effects
were not influenced by maternal  zinc supplementation.

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12.6.2.3   Effects of Lead on Avian Species.   The  effects  of  lead  on  the  reproduction  and
development of various avian species have been studied by a number of investigators,  primarily
because of interest in the effects of lead shot ingested by wildlife or in order to develop an
avian embryo model  for the experimental analysis of  ontogenetic  processes.   The relevance of
such  studies  to  the  health  effects  of lead  on  humans  is  not  clear.   Consequently,  these
studies are not discussed further here.

12.6.3  Summary
     The most clear-cut data described in this section on reproduction and development are de-
rived from studies employing high lead doses in laboratory animals.  There is still a need for
more  critical  research to  evaluate the possible  subtle toxic effects of lead  on the  fetus,
using  biochemical,  ultrastructural,  or behavioral  endpoints.   An  exhaustive  evaluation  of
lead-associated changes in  offspring should include consideration of  possible  effects  due to
paternal lead burden  as well.  Neonatal lead intake via consumption of milk from lead-exposed
mothers may also be a factor at times.  Moreover, it must be recognized that lead's effects on
reproduction  may be  exacerbated  by other  environmental  factors (e.g.,  dietary influences,
maternal hyperthermia, hypoxia, and co-exposure to other toxins).
     There are  currently  no reliable data pointing to adverse effects  in  human offspring fol-
lowing  lead  exposure  of fathers  per se.    Early  studies of  pregnant women exposed to high
levels of lead  indicated  toxic, but not teratogenic, effects on the conceptus.  Unfortunately,
the  collective  human  data  regarding  lead's  effects  on  reproduction  or HI  utero development
currently  do  not  lend  themselves  to accurate  estimation of exposure-effect  or  no-effect
levels.   This  is  particularly  true  regarding  lead  effects  on  reproductive  performance in
women,  which  have  not been well  documented at low  exposure  levels.   Still,  prudence would
argue  for  avoidance of lead  exposures  resulting in blood  lead  levels  exceeding 25-30 [iq/dl in
pregnant  women  or  women  of  child-bearing  age in  general,  given  the equilibration between
maternal  and  fetal blood lead concentrations that occurs and  the growing evidence for dele-
terious effects in young  children  as  blood  lead  levels approach or exceed  25-30 ug/dl.   Indus-
trial  exposure of  men to  lead  at levels  resulting in  blood  lead values of 40-50 ug/dl also
appear to result  in altered testicular function.
      The  paucity of human  exposure  data forces  an examination of the  animal  studies  for indi-
cations  of  threshold levels  for  effects of lead on the  conceptus.   It must be  noted that  the
animal  data  are almost entirely  derived from rodents.  Based  on these rodent data, it seems
likely  that  fetotoxic  effects have  occurred in animals  at  chronic exposures to 600-800  ppm
inorganic  lead  in the diet.   Subtle effects appear to  have  been observed at 5-10 ppm  in the
drinking  water, while  effects of  inhaled  lead have  been seen  at  levels  of 10  mg/m3.   With
multiple  exposure by  gavage, the  lowest  observed effect level  is  64 mg/kg per  day, and  for
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exposure via  injection,  acute doses of  10-16  mg/kg appear effective.  Since  humans  are  most
likely to be exposed to lead in their diet, air, or water, the data from other routes  of expo-
sure are of  less  value in estimating harmful  exposures.   Indeed,  it appears that teratogenic
effects  occur in  experimental animals  only when  the  maternal dose  is  given by  injection.
     Although human and  animal  responses may be dissimilar, the animal evidence does  document
a variety of  effects  of  lead exposure on  reproduction  and development.  Measured or  apparent
changes  in  production of or  response to reproductive hormones, toxic  effects  on  the gonads,
and  toxic  or teratogenic  effects  on the  conceptus have all  been reported.   The  animal  data
also suggest subtle effects on such parameters as metabolism and cell structure that should be
monitored in  human populations.   Well-designed human epidemiological  studies  involving large
numbers  of  subjects are still needed.   Such data could clarify the relationship  of  exposure
levels  and  durations  to  blood lead values  associated with significant effects and are needed
for estimation of no-effect levels.  (Recent studies, most of which are prospective epidemiol-
ogical  investigations, on  the relationship between relatively  low-level   lead  exposure and
effects  on  fetal   and child  development,  along  with supporting  experimental  evidence  on
possible underlying mechanisms, are reviewed in an Addendum to this document.)
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12.7  GENOTOXIC AND CARCINOGENIC EFFECTS OF LEAD
12.7.1  Introduction
     Potential carcinogenic, genotoxic  (referring  to alteration in structure or metabolism  of
DMA), and mutagenic roles of lead are considered here.   Epidemiological  studies of occupation-
ally exposed populations are considered first.   Such studies investigate possible associations
of lead with  induction  of human neoplasia and are important because they assess the incidence
of disease  in humans under actual ambient  exposure conditions.  However,  such studies  have
many  limitations  that make it  difficult  to  assess the carcinogenic activity  of any specific
agent.   These include  general  problems  in  accurately  determining the  amount  and  nature  of
exposure to a particular chemical agent; in the absence of adequate exposure data it is diffi-
cult  to  determine  whether each individual in a population was equally exposed to the agent  in
question.  It is also often difficult to assess other factors, such as exposure to carcinogens
in the  diet,  and  to control for confounding  variables  that may have contributed to the inci-
dence of  any  neoplasms.   These factors tend to obscure the effect of lead alone.  Also, in  an
occupational  setting  a  worker  is often exposed to various chemical  compounds, making it more
difficult to  assess   epidemiologically the injurious effect resulting specifically from expo-
sure to one, such as lead.
     A  second  approach  considered  here examines the ability of  specific lead compounds to in-
duce  tumors  in experimental animals.   The advantage of these studies over epidemiological in-
vestigations  is that  a  specific lead compound, its mode of administration, and  level of expo-
sure  can be  well  defined and  controlled.  Additionally,  many  experimental  procedures can  be
performed on  animals  that for ethical reasons cannot be performed on humans, thereby allowing
a better  understanding  of the course  of  chemically induced injury.   For example, animals may
be sacrificed  and  necropsies  performed at any desired time during the study.  Factors such as
diet  and  exposure  to other environmental conditions can be well controlled, and genetic vari-
ability  can  be  minimized  by  use  of  well established  and characterized  animal  lines.   One
problem with  animal  studies is the difficulty of  extrapolating  such data to humans.  However,
this  drawback  is perhaps  more  important in assessing the toxicity of organic chemicals than in
assessing inorganic agents, because the injury induced by  many organic agents  is highly depen-
dent  upon reactive intermediates formed ;ni vivo by enzymatic action (e.g., microsomal enzymes)
upon  the  parent compound.  In  addition,  both qualitative  and quantitative  differences between
the  metabolic  capabilities of  humans and experimental  animals have  been documented (Neal,
1980).   With inorganic  compounds  of lead, however, the  element of interest  undergoes little
alteration  jn vivo and,  therefore, the  ultimate  toxic agent is less likely to  differ  between
experimental  animals  and  humans  (Costa, 1980).  The carcinogenic action  of  most  organic chemi-
cals  is dependent upon activation  of  a parent pro-carcinogen,  whereas  most metallic  carcino-
gens  undergo  little  alteration  HI vivo to produce  their oncogenic  effects  (Costa, 1980).
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     A  third  approach discussed  below is in vitro  studies.   Animal  carcinogen bioassays are
currently the  preferred  means for assessing  carcinogenic  activity but they are extremely ex-
pensive  and time  consuming.  As  a result,  much effort  has  been directed  toward developing
suitable iji vitro  tests  to complement iji vivo animal studies for the evaluation of the poten-
tial oncogenicity  of chemicals.   The cell transformation assay has as its endpoint neoplastic
transformation of mammalian cells and is the most suitable jn vitro system because it examines
cellular events  closely  related to carcinogenesis (Heck and Costa, 1982a).  A general problem
with this assay  system,  which is less troublesome  with reference to metal compounds, is that
it  employs  fibroblastic  cells in culture,  which lack many jji  vivo  metabolic  systems.   Since
lead is  not extensively  metabolized jn vivo, addition of liver microsomal extracts (which has
been attempted in this and similar systems) is not necessary to generate the ultimate carcino-
gen^) from this metal (see above).   However, if other indirect factors are involved with lead
carcinogenesis in  vivo,  then  these might  be absent in such  culture  systems  (e.g., specific
lead-binding  proteins that   direct  lead  interactions  JH vivo  with oncogenically relevant
sites).  There are  also  technical problems related to the culturing of primary cells and dif-
ficulties with  the  final  microscopic  evaluation of  morphological  transformations,  which are
prone to some subjectivity.  However, if the assay is performed properly it can be very relia-
ble and reproducible.  Modifications of this assay system (i.e., exposure of pregnant hamsters
to  a test chemical  followed by culturing  and examination of embryonic cells for transplacen-
tally  induced  transformation) are  available for evaluation of  iji vivo  metabolic influences,
provided that  the  test agent is transported  to  the fetus.   Additionally, cryopreservation of
primary  cultures isolated  from the same  litter  of  embryos can control  for  variation in cell
populations exposed to test  chemicals  and give more reproducible  responses  in replicate ex-
periments (Pienta,  1980).   A  potential  advantage of the cell  transformation  assay  system is
the possibility  that cultured human cells can be transformed jn vitro.   Despite numerous at-
tempts,  however, no  reproducible  human-cell  transformation  system  has  yet  been sucessfully
established which  has been evaluated with a number of different chemicals of defined carcino-
genic activity.
     Numerous  processes  have  been closely  linked  with oncogenic development,  and specific
assay systems  that  utilize events linked mechanistically with cancer as an endpoint have been
developed to probe whether a chemical agent can affect any of these events.  These systems in-
clude assays for mutations,  chromosomal  aberrations, development  of micronuclei, enhancement
of sister chromatid exchange, effects on DNA structure, and effects on DNA and RNA polymerase.
These assay  systems  have  been used to  examine  the  genotoxicity of  lead and facilitate the
assessment  of  possible  lead  carcinogenicity.   Chromosomal  aberration  studies are  useful
because human lymphocytes cultured from individuals after exposure to lead allow evaluation of

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genotoxic activity  that occurred  under the  influence  of an ijn vivo metabolic  system.   Such
studies are discussed below in relationship to genotoxic effects of lead.   However,  a neoplas-
tic change  does not  necessarily  result,  and evaluations of  some less conspicuous  types  of
chromosomal aberrations  are somewhat  subjective  since microscopy  is exclusively  utilized  in
the final analyses.   Nevertheless,  it is reasonable to assume that if an agent produces chro-
mosomal aberrations  it may  have  potential carcinogenic activity.   Many carcinogens  are  also
mutagenic,  and  this  fact,  combined with the  low  cost and ease with which  bacterial  mutation
assays can  be  performed,  has resulted  in  wide use of these  systems  in determining potential
careinogenicity of chemicals.  Mutation assays can also be performed with eukaryotic cells and
several studies are discussed below that examined the mutagenic role of lead in these systems.
However,  in bacterial systems such as the Ames test, metal compounds with known human carcino-
genic activity  are  generally negative and, therefore, this system is not useful for determin-
ing the  potential  oncogenicity of  lead.   Similarly, even in  eukaryotic  systems,  metals  with
known  human cancer-causing  activity  do not  produce  consistent mutagenic  responses.   Reasons
for this  lack  of mutagenic effect remain unclear, and it appears  that mutagenicity studies of
lead cannot be weighed heavily in assessing its genotoxicity.
     Other test systems that probe for effects of chemical agents  on DMA structure may be use-
ful in  assessing the  genotoxic potential  of  lead.   Sister  chromatid  exchange represents the
normal movement  of  DNA in the genome  and  enhancement of this process by potentially carcino-
genic  agents  is a  sensitive indicator  of genotoxicity  (Sandberg,  1982).   Numerous recently
developed techniques can be used to assess DNA damage induced by chemical carcinogens.  One of
the most  sensitive  is  alkaline elution (Kohn et  al.,  1981), which may be  used to study DNA
lesions produced jn  vivo  or in cell culture.  This technique can  measure DNA  strand breaks or
crosslinks  in  DNA,  as well as repair of these lesions, but the toxicity of  lead compounds has
not been  studied with  this  technique.   Assessment of the induction  of DNA repair represents
one of the most sensitive  techniques  for  probing genotoxic  effects.   The  reason  for this is
that the other procedures measure DNA lesions that have persisted  either because they were not
recognized  by  repair enzymes or  because their number was sufficiently great to saturate DNA
repair systems.  Measurement of DNA repair activation is  still  possible even if  the DNA lesion
has been  repaired,  but effects of  lead compounds  on DNA repair have not been studied.  There
are a few isolated experiments within publications that examined the ability of  lead compounds
to  induce DNA damage, but  this line  of investigation requires  further work.  There are some
well-conducted jn vitro studies of the  effect of lead along with other  water soluble metals on
isolated  DNA  and  RNA  polymerases,  which  suggest  mutagenic mechanisms  occurring in intact
cells.   The ability  of lead to  affect the  transcription  of  DNA and RNA  merits  concern in
regard to its potential oncogenic and mutagenic properties.

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12.7.2  Carcinogenesis Studies of Lead and its Compounds
12.7.2.1  Human Epidemiclogical Studies.  Epidemiologies! studies of industrial workers, where
the  potential  for lead exposure is  usually  greater than for a "normal population," have been
conducted  to evaluate the  role of  lead in  the  induction of  human  neoplasia (Cooper, 1976,
1981;  Cooper and  Gaffey,  1975; Chrusciel, 1975;  Dingwall-Fordyce  and Lane, 1963; Lane, 1964;
McMichael  and Johnson,  1982; Neal  et  al.,   1941;  Nelson et  al.,  1982).   In  general, these
studies made no  attempt to consider  types of lead compounds to which workers were exposed or
to determine probable routes of exposure.  Some information on specific lead compounds encoun-
tered  in  the  various  occupational  settings, along with  probable  exposure  routes,  would have
made the  studies  more interpretable  and useful.  As noted in Chapter 3, with the exception of
lead nitrate and  lead acetate, many  inorganic  lead salts are relatively water insoluble.   If
exposure  occurred by  ingestion, the ability of water-insoluble lead  salts (e.g.,  lead oxide
and  lead sulfide) to dissolve in the  gastrointestinal tract may contribute  to understanding of
their  ultimate systemic  effects in comparison to  their  local  actions in the gastrointestinal
tract.  Factors such  as  particle size are also  important in the dissolution of any water in-
soluble compounds in the  gastrointestinal   system  (Mahaffey,  1983).   When considering other
routes of  exposure  (e.g.,  inhalation),  the water solubility of the lead compound in question,
as well  as the particle size,  are  extremely important,   both  in terms of   systemic absorption
and  contained injury  in  the immediate  locus of the  retained particle (see  Chapter 10).   A
hypothetical example is the inhalation of an  aerosol of  lead oxide versus a water soluble lead
salt such  as lead acetate.   Lead oxide particles having  a diameter of <5 Mm would tend to de-
posit  in  the lung and remain  in contact with cells there until they dissolved, while soluble
lead salts  would  dissipate  systemically at  a much more  rapid rate.  Therefore, in the case of
inhaled particulate  compounds, localized  exposure to lead might  produce  injury primarily in
respiratory  tissue, whereas  with  soluble salts, systemic (i.e., CNS, kidney, and erythropoie-
tic) effects might predominate.
     The studies  of Cooper and Gaffey (1975)  and Cooper  (1976, 1981) examined the incidence of
cancer in a  large population of industrial workers exposed to lead.  Two groups of individuals
were identified as  the lead-exposed  population under consideration:   smelter workers from six
lead production facilities  and battery plant workers  (Cooper  and  Gaffey,   1975).  The authors
reported (see Table 12-17) that total mortality from cancer was higher in lead smelter workers
than in  a control population  in two ways:    (1) the difference between  observed and expected
values for the types of malignancies  reported; and (2) the standardized mortality ratio (SMR),
which,  by comparison  to  a control  population, indicates a greater than "normal" (but not nec-
essarily statistically significant) response  if it is in excess of 100 percent.  These studies
report not  only an  excess  of all  forms  of  cancer in smelter workers but also a greater level
of cancer in the  respiratory and digestive systems in both battery plant and smelter workers.
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   TABLE 12-17.   EXPECTED AND OBSERVED DEATHS AND STANDARDIZED  MORTALITY  RATIOS FOR MALIGNANT
     NEOPLASMS FROM JAN.  1,  1947 TO DEC.  31,  1979 FOR LEAD  SMELTER  AND  BATTERY PLANT WORKERS
Causes.of death
(ICDa Code)
All malignant neoplasms (140-205)
Buccal cavity & pharynx (140-148)
Digestive organs peritoneum (150-159)
Respiratory system (160-164)
Genital organs (170-179)
Urinary organs (180-181)
Leukemia (204)
Lymphosarcoma, lymphatic, and
hematopoietic (200-203, 205)
Other sites
Smelters
Observed
69
0
25
22
4
5
2

3
8
Expected
54.95
1.89
17.63
15.76
4.15
2.95
2.40

3.46
6.71
h
5MRD
133
—
150
148
101
179
88

92
126
Battery Plant
Observed
186
6
70
61
8
5
6

7
23
Expected
180.34
6.02
61.48
49.51
18.57
10.33
7.30

9.74
17.39

5MIT
111
107
123
132
46
52
88

77
142
International Classification of Diseases.
 Correction of +5.55% applied for 18 missing death certificates; SMR = standardized mortality
 ratio.
Correction of +7.52% applied for 71 missing death certificates.
Source:  Cooper and Gaffey (1975).

The incidence  of  urinary system cancer was  also  elevated in the smelter workers  (but  not  in
the battery plant workers), although the number of individuals who died from this neoplasm was
very small.  As the table indicates, death from neoplasm at other sites was also elevated com-
pared  with a normal population,  but  these  results were not discussed  in  Cooper and Gaffey1s
(1975) report, since these elevated incidences of cancer were not statistically significant  by
their analysis.
     Kang et al. (1980) examined the Cooper and Gaffey (1975) report and noted an error in the
statistical equation used to assess the significance of excess cancer mortality.  Table 12-18,
from Kang  et al.  (1980) shows  results  based on what they claimed was a corrected form of the
statistical  equation  previously  used  by Cooper  and Gaffey (1975);  it also employed another
statistical  test  claimed  to  be more  appropriate.   Statistical  significance  was observed  in
every category listed with the  exception of battery plant workers, whose deaths  from all forms
of  neoplasia were  not  different  from a control population.  Gaffey  (1980), in responding to
the letter of Kang et al.  (1980),  indicated  that a typographical error had been made in the
equation printed  in their publication  (Cooper and Gaffey, 1975)  but that the  correct equation
had actually been used  in assessing the statistical  significance  of their data.
     Cooper  and Gaffey (1975)  did not  discuss  types of lead compounds that these workers may
have  been  exposed  to  in  smelting  operations,  but  workers  thus employed  likely ingested or
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   TABLE 12-18.  EXPECTED AND OBSERVED DEATHS RESULTING FROM SPECIFIED MALIGNANT NEOPLASMS
           FOR LEAD SMELTER AND BATTERY PLANT WORKERS AND LEVELS OF SIGNIFICANCE BY
                  TYPE OF STATISTICAL ANALYSIS ACCORDING TO ONE-TAILED TESTS
Probability
Number of deaths
Causes of death
(ICDa code)
Ob-
served
Ex- ,
pected SMRD
Pois-
son
This
anal ^
ysis
Cooper
and
Gaffey6
Lead smelter workers:
                                   69
                                   25
All malignant neoplasms
  (140-205)
Cancer of the digestive organs,
  peritoneum (250-159)
Cancer of the respiratory system   22
  (160-164)
Battery plant workers:
54.95     133       <0.02       <0.01     <0.02
17.63     150       <0.03       <0.02     <0.05
15.76     148       <0.05       <0.03     >0.05
All malignant neoplasms
(140-205)
Cancer of the digestive organs,
peritoneum (150-159)
Cancer of the respiratory system
(160-164)
186

70

61

180.34

61.48

49.51

111

123

132

>0.05

<0.05

<0.03

>0.05

<0.04

<0.02

>0.05

>0.05

<0.03

 International Classification of Diseases.
 Standardized mortality ratios (SMRs) were corrected by Cooper and Gaffey for missing death
 certificates under the assumption that distribution of causes of death was the same in
 missing certificates as in those that were obtained.
 Observed deaths were recalculated as follows: adjusted observed deaths = (given SMR/100) x
 expected deaths.
JGiven 2 = (SMR - 100) ,/expected/lOO.
eGiven 2 = (SMR - 100)//100 x SMR/expected.
Source:  Kang et al. (1980).
inhaled oxides and sulfides of lead.  Since these and other lead compounds produced in the in-
dustrial setting are not readily soluble in water it could be that the cancers arising in res-
piratory  or gastrointestinal  systems were  caused  by  exposure  to water-insoluble  lead com-
pounds.  Although  the  Cooper and Gaffey (1975)  study  had a large sample (7032), only 2275 of
the  workers (32.4 percent)  were employed  when plants  monitored  urinary lead.  Urinary lead
values were  available  for only 9.7 percent of  the  1356 deceased employees on whom the cancer
mortality  data  were  based.   Only 23  (2  percent) of the 1356 decedents  had  blood lead levels
measured.   Cooper  and Gaffey  (1975)  did  report some average urinary  and  blood lead levels,
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where  10 or  more urine  or  at  least  three blood  samples were  taken  (viz.,  battery  plant
workers:  urine  lead =  129 ug/1,  blood lead =  67  ug/dl;  smelter workers:   urine lead  =  73
(jg/1,  blood  lead  =  79.7  ug/dl).   Cooper  (1976)  noted that  these  workers were  potentially
exposed  to  other  materials, including arsenic,  cadmium, and sulfur  dioxide,  although no data
on  such  exposures  were  reported.   In these  and  other  epidemiological  studies in  which selec-
tion of  subjects  for monitoring exposure to an  agent  such as  lead is left to company discre-
tion,  it is possible that  individual subjects are monitored primarily on the basis of obvious
signs  of lead exposure,  while other  individuals who show  no symptoms of lead poisoning would
not be monitored  (Cooper and Gaffey, 1975).  It is also not clear from these studies when the
lead  levels were  measured,  although the timing of measurement would make little difference
since  no attempt  was made  to  match an  individual's  lead  exposure  to  any  disease process.
     In  a follow-up  study of the same population of workers, Cooper (1981) concluded that lead
had  no  significant  role  in the induction  of  neoplasia.   However, he did  report  SMRs of 149
percent  and 125  percent  for all  types of  malignant neoplasms in lead  battery plant workers
with <10 or >10 years of employment,  respectively (Cooper, 1981).   In battery workers employed
for  10 years  or more there  was  an unusually high incidence of cancer  listed as  "other site"
tumors (SMR =  229  percent;  expected = 4.85,  observed = 16) (Cooper, 1981, Table 13).  Respira-
tory  cancers  were  elevated  in  the  battery plant  workers employed  for  less than 10 years
(SMR = 172  percent).  Similarly,  in  workers involved with lead production  facilities for more
than 10  years  the  SMR was 151 percent.
     An  analysis   of data  for a  more carefully selected  subset  of  the  same population (6819
workers  versus 7032 originally)  for  the  period 1947-1980 was  recently  reported  by  Cooper
(1985).   Deaths due to malignant  neoplasms were elevated in  both cohorts  of workers (SMRs =
113  percent),  a significant excess  in  battery workers but not in  smelter workers because of a
smaller number of cases.   Most  of these deaths  occurred prior to  1971, which accounts  for the
lack  of such  findings in Cooper's (1981) analysis of  1971-1975 data.  Consistent with  earlier
findings, the primary tumor sites  were  the  gastrointestinal  tract  and the  lung.  Cooper  (1981,
1985)  noted that  the lack  of  information on smoking histories made  interpretation of the  res-
piratory cancers  problematic.   However, the association  of lead  exposure with gastric  cancer
is  consistent with  findings of  Sheffet et  al.   (1982), who  reported  an  increased,  albeit  non-
significant,  incidence  of  stomach cancer in workers  exposed  to  lead  chromate.   Cooper (1985)
suggested that high  local  concentrations of ingested lead  could have  a co-carcinogenic effect,
particularly  in those whose dietary  or  alcohol  intake  patterns predispose  them  to  higher-than-
average gastric cancer rates.   As noted  by Cooper, further study of the  possible association
between lead  and  gastric cancer  seems advisable.   At present,  however, without  better docu-
mentation of  lead exposure  histories, it  is difficult  to  assess the  degree of lead's contribu-
tion to the above findings.
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     A  recent study  (McMichael  and Johnson,  1982)  examined  the  historical  incidence of cancers
 in  a population of  smelter workers  diagnosed  as having  lead poisoning.  The incidence of can-
 cer in  a relatively small group  of  241 workers was  compared with 695 deceased employees from
 the same company.   The  control group had been employed during approximately  the same period
 and was asserted to be  free  from lead exposure,  although  there were no data to  indicate lead
 levels  in either the control or  the experimental  group.  Based upon diagnoses of lead poison-
 ing made  in the  1920s and 1930s for  a majority of  the deaths, the authors  concluded that there
 was a  considerably lower incidence  of cancer  in lead-poisoned workers (McMichael and Johnson,
 1982).   However, there  is no indication of  how lead poisoning was diagnosed.  It is difficult
 to  draw any conclusions from this study  with  regard to  the role  of lead in human neoplasia.
     Davies (1984)  found that workers exposed to  both  lead and zinc chromate in English pig-
 ment factories  showed a  significantly increased  incidence of  lung  cancer mortality  after at
 least  one year  of medium or  high  exposure.   However,   lung  cancer mortality was  normal  in
 workers  exposed  only to  lead chromate,  thus suggesting  that zinc rather  than  lead chromate,
 was the more  significant risk factor.
     Another  recent epidemiological  study (Selevan et al.,  1984) has noted increased mortality
 from renal  cancer in a group of  lead smelter  workers.    The SMR for deaths from renal cancer
 was 204 percent for the  entire cohort,  although  this excess mortality  was not statistically
 significant and  only, represented 6  cases.   However, of interest is the  fact  that the renal
 cancers observed in  humans  in  this  study matched the types of cancers induced in experimental
 animals  by  lead.  This  study  also  analyzed the   number of deaths  associated  with high lead
 exposure  in combination  with  other  contaminants (i.e.,   cadmium, zinc, and arsenic) as well as
 those deaths  associated  predominantly with  high lead exposure alone.  The SMR for deaths from
 renal cancer  in the  high lead exposure  areas only was  301 percent.   Similarly,  deaths from
 cancers of  the urinary  organs  had an SMR  of 199  percent in the  high-lead-only group.   These
 results  suggest  that lead exposure  could  be associated with an increased incidence  of renal
 cancer  in humans, but in the absence of statistical significance and  corroboration  by other
 epidemiological  studies, this finding should be interpreted with caution.
     Two  case studies have also  suggested  an  association  of lead exposure  with  renal  cancer
 (Baker  et al., 1980;  Lilis,  1981).   The relatively  high degree of lead exposure in these two
 case reports was well documented by  symptoms of lead intoxication and by measurements of blood
 lead and erythrocyte protoporphyrin.   Furthermore, Baker et al.  (1980) found a relatively high
 concentration  of lead  (~2.5  M9/9) in the patient's  tumor as well  as certain histologic simi-
 larities  to  lead-induced neoplasms  in animal  kidneys  (e.g.,   swollen  mitochondria,  numerous
 dense lysosomes,  and some amphophilic intranuclear inclusion bodies in epithelial cells adja-
 cent to the proximal convoluted tubules).   The generally sparse  presence of intranuclear in-
clusion bodies in  the patient's  kidney was  attributed  to his  use of oral penicillamine three
to  four weeks prior to being examined.
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     Conclusions regarding  the ability of  lead  to induce human neoplasia must  await  further
epidemiological studies in which other factors that may contribute to the observed effects  are
well controlled  for and the disease  process  is  assessed in individuals with  well  documented
exposure  histories.   Little  can now be  reliably concluded  from available  epidemiological
studies.
12.7.2.2    Induction  of Tumors in Experimental Animals.    As   discussed  in  the   preceding
sections,  it  is difficult to  obtain  conclusive  evidence of the carcinogenic  potential  of an
agent  using  only epidemiological studies.   Experiments  testing the ability of  lead to cause
cancer  in  experimental  animals  are  an essential aspect of  understanding  its  oncogenicity in
humans.  However, a proper lifetime animal feeding study to assess the carcinogenic potential
of lead following National Cancer Institute guidelines (Sontag et al., 1976) has not been con-
ducted.   The  cost  of  such studies exceeds  $1 million; consequently they  are  limited  ohly to
those  agents   in  which  sufficient  evidence  based upon jr\  vitro or  epidemiological  studies
warrants  such an undertaking.   The   literature  on lead carcinogenesis  contains many  smaller
studies  where only  one or two doses  were employed and where  toxicological  monitoring of  ex-
perimental animals exposed to  lead was generally absent.  Some of these studies are summarized
in  Table 12-19  (see  also Section 12.8.2.2).   Most mainly  serve  to  illustrate  that numerous
different  laboratories  have  induced  renal tumors  in rats by feeding them  diets containing 0.1
or  1.0 percent  lead  acetate.    In some  cases,  other  lead  formulations were  tested,  but  the
dosage  selection was  not based  upon  lethal  dose values.   In most cases,  only one dose level
was  used.   Another  problem with many of  these studies was  that  the  actual  concentrations of
lead administered and internal body burdens achieved were not measured.  Some  of these studies
are  discussed very  briefly;  others are omitted  entirely because they contribute little to our
understanding  of lead carcinogenesis.
     Administration of  1.0 percent lead  acetate  (10,000  ppm)  resulted in kidney damage and  a
high  incidence of mortality  in most of  the  studies  in  Table 12-19.   However,  kidney tumors
were also evident  at  lower dosages  (e.g.,  0.1 percent lead acetate  in  the diet), which  pro-
duced  less mortality  among the  test  animals.   As discussed in  Section  12.6,  renal damage is
one of  the primary toxic effects of lead.  At  0.1  percent lead  acetate (1000 ppm)  in the diet,
the  concentration of  lead measured in the  kidney  was  30 |jg/g while 1 percent  lead  acetate re-
sulted  in 300 ug/g  of  lead in the kidneys of  necropsied animals  (Azar et  al., 1973).   In  most
of  the studies with rats  fed  0.1 or  1.0  percent lead  in the diet, the incidence  of kidney tu-
mors increased between the lower and higher  dosage, suggesting a  relationship between the de-
position  of  lead in the  kidney  and the carcinogenic response.   Renal  tumors were  also induced
in  mice at the 0.1 percent oral dosage of  lead  subacetate but not in  hamsters that were simi-
larly  exposed to this agent (Table 12-19).

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TABLE 12-19.  EXAMPLES OF STUDIES ON THE INCIDENCE OF TUMORS IN EXPERIMENTAL
                      ANIMALS EXPOSED TO LEAD COMPOUNDS
Species
Rat
Rat
Rat
Mouse
Rat
Rat
Rat
Mouse
Rat
Hamster
Mouse
Rat
Rat
Pb compound
Pb phosphate
Pb acetate
Pb
subacetate
Pb
naphthenate
Pb phosphate
Pb
subacetate
Pb
subacetate
Tetraethyl
lead in
tricaprylin
Pb acetate
Pb
subacetate
Pb
subacetate
Pb nitrate
Pb acetate
Dose and mode*
120-680 rag
(total dose s.c.)
1% (in diet)
0.1% and
1.0% (in diet)
20% in benzene
(dermal 1-2
times weekly)
1.3 g (total
dosage s.c.)
0.5 - 1%
(in diet)
1% (in diet)
0.6 mg (s.c. )
4 doses between
birth and 21 days
3 ing/day for
2 months;
4 mg/day for
16 months (p.o. )
1.0% (in
0.5% diet)
0.1% and
1.0% (in diet)
25 g/1 (in
drinking water)
3 mg/day (p.o.)
Incidence (and type) of
neoplasms
19/29 (renal tumors)
15/16 (kidney tumors)
14/16 (renal carcinomas)
11/32 (renal tumors)
13/24 (renal tumors)
5/59 (renal neoplasms)
(no control with
benzene)
29/80 (renal tumors)
14/24 (renal tumors)
31/40 (renal tumors)
5/41 (lymphomas)
in females, 1/26 in
males, and 1/39 in
controls
72/126 (renal tumors)
23/94 males (testicular
[Leydig cell] tumors)
No significant incidence
of renal neoplasms
7/25 (renal carcinomas)
at 0.1%; substantial
death at 1.0%
No significant incidence
of tumors
89/94 (renal, pituitary,
cerebral gliomas,
adrenal, thyroid, pro-
Reference
Zol linger
(1953)
Boy land et
al. (1962)
Van Esch
et al. (1962)
Baldwin et
al. (1964)
Balo et al.
(1965)
Hass et al.
(1967)
Mao and
Molnar (1967)
Epstein and
Mantel (1968)
Zawirska and
Medras (1968)
Van Esch and
Kroes (1969)
Van Esch and
Kroes (1969)
Schroeder et
al. (1970)
Zawirska
and
Medras*. 1972
                                           static,  mammary tumors)
                                 12-230

-------
                                        TABLE  12-19.   (continued)
 Species     Pb  Compound     Dose  and  mode
                                        Incidence (and type)  of
                                               neoplasms
                                                     Reference
 Rat
Pb acetate
 Hamster    Pb oxide
 Rat
Pb chromate
0, 10, 50, 100,
1000, 2000 ppm
(in diet) for
2 yr
               1 mg (intratracheal)
               10 times
8 mg (i.m.)
for 9 monthly
injections
No tumors 0-100 ppm;         Azar et al.
5/50 (renal  tumors) at      (1973)
500 ppm; 10/20 at 1000 ppm;
16/20 males, 7/20 females
at 2000 ppm
0/30 without benzopyrene,
12/30 with benzopyrene
(lung cancers)

Females: 2/25 lymphoma,
11/25 fibrosarcoma,
10/25 rhabdomyosarcoma,
1/25 osteogenic sarcoma
Males: 3/25 fibrosarcoma,
7/25 rhabdomyosarcoma,
3/25 renal carcinoma
Kobayashi
and
Okamoto (1974)

Furst et al.
(1976)
Mouse
Rat
Pb chromate 3 mg (i.m.)
for 4 monthly
injections
Pb acetate 0, 26, 2600 ppm
(in drinking water)
for 76 wk
Females only:
2/25 lymphoma,
3/25 lung carcinoma
81% (renal tumors)
at 2600 ppm
Furst et al.
(1976)
Koller et al.
(1985)
*s.c.  = subcutaneous injection; p.o.  = per os (gavage); i.m. = intramuscular injection.


     Other lead compounds  have also  been tested in experimental animals, but in these studies

only one  or  two dosages (generally  quite  high) were employed, making  it  difficult to  assess

the potential  carcinogenic activity  of lead compounds  at relatively nontoxic concentrations.

It is  also difficult to assess the  true  toxicity caused by these  agents,  since properly de-

signed  toxicity studies were  generally  not performed  in parallel  with these cancer studies.

     As shown  in  Table 12-19, lead  nitrate  produced no tumors in  rats when given at very low

concentrations, but  lead  phosphate administered subcutaneously at  relatively high levels in-

duced  a high incidence of  renal  tumors  in two studies.   Lead  powder administered orally re-

sulted  in lymphomas and  leukemia; when  given  intramuscularly  only one fibrosarcoma was pro-

duced  in  50  animals.  Lead naphthenate applied as a 20  percent solution  in benzene two times

each week for  12 months resulted in the development of four  adenomas  and one  renal carcinoma

in a  group  of  50 mice  (Baldwin  et al.,  1964).  However,  in  this   study control mice were not
                                          12-231

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painted with benzene.  Tetraethyl lead at 0.6 mg given in four divided doses between birth and
21 days  to  female mice resulted in 5 of 36 surviving animals developing lymphomas, while 1 of
26  males treated  similarly  and 1 of  39 controls  developed  lymphomas (Epstein  and  Mantel,
1968).
      Lead subacetate  has  also been tested in the  mouse  lung adenoma bioassay (Stoner et al.,
1976).   This  assay measures the incidence of  nodules forming in the  lung  of strain A/Strong
mice  following parenteral administration of various test agents.   Nodule formation in the lung
does  not  actually  represent the induction of lung cancer but merely serves as a general meas-
ure of carcinogenic potency independent of lung tissue (Stoner et al., 1976).   Lead subacetate
was  administered  to  mice  at 150, 75,  and 30  mg (total  dose), which  represented the  maximum
tolerated dose (MTD), 1/2 MTD, and 1/5 MTD, respectively, over a 30-week period using 15 sepa-
rate  i.p.  injections (Stoner et al., 1976).   Survivals  at the three  doses were  15/20 (MTD),
12/20  (1/2  MTD),  and 17/20  (1/5 MTD),  respectively, with 11/15,  5/12,  and  6/17  survivors
having lung nodules.   Only at the highest doses was the incidence of nodules greater than in
the  untreated mice.   However,  these  authors  concluded that on a molar-dose basis lead subace-
tate  was  the  most potent of  all  the  metallic  compounds  examined.   Injection  of  0.13  mmol/kg
lead  subacetate was  required to produce  one lung  tumor  per mouse,  indicating  that  this com-
pound was about  three times more potent  than  urethane (at 0.5 mmol/kg) and  approximately 10
times more  potent  than nickelous acetate (at 1.15  mmol/kg).   The mouse lung adenoma bioassay
has been widely  utilized  for examining carcinogenic activity of chemical agents in experimen-
tal  animals and  is well recognized as  a  highly accurate test system  for  assessing potential
carcinogenic  hazards of metals  and  their compounds (Stoner et  al.,  1976).    Recent  studies
utilizing the  lung tumor bioassay in  strain A mice  have demonstrated  that administration of
magnesium or calcium  acetates along  with lead  subacetate  eliminated the tumorigenic activity
of  lead  in  this  test system  (Poirier  et al.,  1984).  These results  indicate that essential
divalent metals  can  protect  against  the carcinogenic effects  of  lead.   Lead oxide combined
with  benzopyrene administered  intratracheally  resulted in 11 adenomas and 1 adenocarcinoma in
a group of 15  hamsters, while no lung neoplasias were observed in groups receiving benzopyrene
or lead oxide  alone (Kobayashi and Okamoto, 1974).
     Administration  of lead  acetate  to  rats   has  been  reported  to  produce other types  of
tumors,  e.g.,  testicular,  adrenal, thyroidi  pituitary,  prostate,  lung  (Zawirska and  Medras,
1968), and  cerebral  gliomas  (Oyasu  et al., 1970).   However,  in  other animal  species,  such as
dogs  (Azar  et al.,  1973;  Fouts and Page,  1942) and hamsters (Van Esch and Kroes, 1969), lead
acetate induced either no tumors or only kidney tumors (Table 12-19).
     The above  studies seem  to  implicate some lead  compounds as  carcinogens in experimental
animals,  but they  were not designed to address the question of lead carcinogenesis in a defi-
nitive manner.   In contrast, a study by Azar et al.  (1973) examined the oncogenic potential of
                                          12-232

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lead acetate at  a  number of doses and  in addition monitored a number  of  toxicological  para-
meters in the  experimental  animals.   Azar et al.  (1973)  gave 0,  10, 50,  100,  500,  1000,  and
2000 ppm dose levels of lead (as lead acetate) to rats during a two-year feeding study.   Fifty
rats of each sex were utilized at doses of 10-500 ppm, while 100 animals of each sex were used
as controls.   After  the study was under  way  for a few months, a  second  2-year feeding study
was initiated using 20 animals of each sex in groups given doses of 0, 1000, or 2000 ppm.   The
study also  included  four male and four female beagle dogs at each dosage of lead ranging from
0 to 500 ppm in a 2-year feeding study.  During this study, the clinical appearance and behav-
ior of the  animals  were observed, and  food  consumption,  growth,  and mortality were recorded.
Blood, urine,  fecal,  and tissue lead analyses were  done  periodically using atomic absorption
spectrophotometry.    A  complete  blood  analysis  was  done periodically, including  blood  cell
count, hemoglobin,  hematocrit, stippled  cell  count,  prothrombin  time, alkaline phosphatase,
urea nitrogen, glutamic-pyruvate transaminase, and albumin-to-globulin ratio.  The activity of
the enzyme  delta-aminolevulinic  acid dehydrase  (ALA-D) in  the blood and the excretion of its
substrate, delta-aminolevulinic acid (ALA), in the urine  were also determined.  A thorough ne-
cropsy, including both gross and histologic examination,  was performed on all animals.
     Table 12-20 depicts  the  mortality and incidence  of  kidney tumors  reported by Azar et al.
(1973).   At  500  ppm (0.05 percent) and above, male  rats  developed a  significant number of re-
nal tumors.   Female  rats did  not develop tumors except  when  fed  2000  ppm lead acetate.   Two
out of four male dogs fed 500  ppm developed a slight  degree of cytomegaly  in the proximal con-
voluted tubule but did  not develop any  kidney tumors.  The  number  of  stippled erythrocytes in-
creased at  10  ppm  in the rats but  not until 500  ppm in  the dogs.   ALA-D  was decreased at 50
ppm in the  rats  but not  until 100  ppm in the dogs.   Hemoglobin and  hematocrit, however, were
not depressed  in the rats until  they  received a dose of 1000 ppm lead.   These results illus-
trate  that the  induction of  kidney  tumors coincides with moderate  to  severe toxicological
doses  of  lead acetate,  for it was at  500-1000  ppm lead  in  the  diet that  a significant in-
crease in mortality occurred  (see Table  12-20).   At 1000 and 2000 ppm lead, 21-day-old wean-
ling rats showed no  tumors but did show histological  changes  in the  kidney comparable to those
seen  in  adults receiving 500  ppm or  more lead  in their  diet.  Also  of interest from the Azar
et  al.  (1973) study is  the  direct  correlation obtained  in  dogs  between  blood lead level and
kidney lead concentrations.  A dietary  lead  level  of  500 ppm  produced  a  blood  lead concentra-
tion  of  80 pg/dl within 24 months, which corresponds to  a  level  at which humans  often  show
clinical  signs of  lead poisoning (see Section 12.4.1).   The kidney  lead  concentration  corres-
ponding  to this blood lead level was  2.5 |jg/g  (wet  weight), while  at 50 pg/dl  in blood the
kidney  lead levels  were 1.5  ug/g.   Assuming  similar pharmacokinetic distribution  of  lead  in
                                           12-233

-------
        TABLE  12-20.   MORTALITY  AND KIDNEY TUMORS  IN  RATS  FED  LEAD  ACETATE  FOR TWO YEARS
Nominal (actual)
concentration in
ppm of Pb in diet
0 (5)
10 (18)
50 (62)
100 (141)
500 (548)
0 (3)
1000 (1130)
2000 (2102)
No. of rats
of each sex
100
50
50
50
50
20
20
20
%
Male
37
36
36
36
52
50
50
80
mortality
Female
34
30
28
28
36
35
50
35
% Kidney tumors
Male Female
0 o
0 0
0 0
0 0
10 0
0 0
50 0
80 35
 Measured concentration of  lead  in diet.
 Includes rats that either  died  or were sacrificed  ui extremis.
Source: Azar et al. (1973).

the  dogs  as in rats, it can  be  stated that chronic exposure to 500 ppm of dietary lead, pro-
ducing  prolonged  elevation of  blood lead  to  80 ug/dl and  resulting in a  concentration  of
2.5  MQ/g in the kidney can  cause elevation in the incidence of kidney tumors.
     Animal  carcinogenesis  studies conducted  with lead and  its  compounds  are numerous; how-
ever, with  the exception  of the study  by Azar et al.  (1973), they do not provide much useful
information.   Most of the  studies shown  in Table 12-18 were conducted with only one lead com-
pound  in  one  animal  species,  the rat.   In cases  where other lead compounds were  tested  or
where  other animal species were used,  only  a  single high dosage  level  was  administered, and
parameters  of  toxicity  such as those monitored  in  the  Azar et al. (1973) study were not mea-
sured.  Although  it  is  clear from these  studies as a whole that  lead is  a carcinogen in ex-
perimental animals, until  more investigations such as that of Azar et al. (1973) are conducted
it is  difficult  to determine the relative carcinogenic potency of lead.  There remains a need
to test thoroughly the carcinogenic activity of  lead compounds in experimental animals.   These
tests should include  several  modes of administration, many dosages spanning non-toxic as well
as toxic levels, and several different lead compounds or at least a comparison of a relatively
water-soluble form such as  lead acetate with a less soluble form such as lead oxide.
12.7.2.3  Cell Transformation.   Although  cell  transformation is an in vitro experimental sys-
tem,  its end point is a neoplastic change.  There are two types of cell transformation assays:
(1) those employing continuous cell lines; and (2) those employing cell cultures prepared from
embryonic tissue.   Use  of  continuous cell lines has  the advantage of  ease  in preparation  of
                                          12-234

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the cell cultures,  but  these cells generally have  some  properties  of a cancer cell.   The ab-
sence of a  few  characteristics of a cancer  cell  in these continuous cell  lines allows for an
assay of cell  transforming activity.   End points include morphological transformation  (ordered
cell  growth to  disordered  cell  growth), ability  to form  colonies in soft  agar-containing
medium (a property  characteristic  of cancer cells), and  ability  of cells  to form tumors when
inoculated  into  experimental animals.    Assays  that utilize freshly  isolated  embryonic cells
are generally  preferred to  those  that  use  cell  lines,  because embryonic cells  have  not yet
acquired  any  of the  characteristics of  a  transformed cell.   The  cell transformation assay
system has  been  utilized  to examine the potential carcinogenic activity of a number of chemi-
cal agents, and  the results seem to agree generally with the results of carcinogenesis tests
using experimental  animals.   Cell  transformation assays can be made quantitative by assessing
the percentage of surviving colonies exhibiting morphological transformation.  Verification of
a  neoplastic  change can be  accomplished  by  cloning these cells and  testing their ability to
form tumors in animals.
     Lead acetate has been shown to induce morphological transformation in  Syrian hamster em-
bryo  cells  following a continuous  exposure to  1 or 2.5 pg/ml of  lead  in culture medium for
nine days (DiPaolo et al., 1978).  The incidence of transformation  increased from 0 percent in
untreated cells  to  2.0  and 6.0 percent of the surviving cells, respectively, following treat-
ment with lead acetate.   Morphologically transformed cells were capable of forming fibrosarco-
mas when cloned and administered to "nude" mice and Syrian hamsters, while no tumor growth re-
sulted  from similar inoculation  with  untreated  cells (DiPaolo et al.,  1978).   In  the same
study, lead acetate was shown to enhance the  incidence of  simian  adenovirus (SA-7) induction
of  Syrian hamster embryo  cell transformation.    Lead  acetate also caused  significant enhance-
ment  (~2-  to  3-  fold)  at  100 and  200  ug/ml  following three  hours  of exposure.  In  another
study  (Casto  et al., 1979),  lead oxide  also  enhanced  SA-7 transformation of Syrian  hamster
embryo cells  almost 4-fold at 50 pM following  three hours  of  exposure  (Casto et al., 1979).
The  significance of enhanced virally  induced carcinogenesis  in  relationship to the carcino-
genic potential of an agent  is not well  understood.
     Morphological  transformation  induced by lead  acetate was  correlated  with the ability of
the transformed cells to form  tumors in  appropriate hosts (see  above),  indicating that  a  truly
neoplastic  change occurred in tissue culture.   The induction of neoplastic  transformation by
lead acetate suggests that this agent is potentially carcinogenic at  the cellular level.   How-
ever, with  iji vitro systems  such as the cell  transformation  assay it  is  essential to  compare
the  effects of  other,  similar types of  carcinogenic agents in order to evaluate the  response
and  to  determine the reliability of the assay.   The  incidence  of transformation  obtained with
lead acetate was greater than  the incidence  following  similar  exposure  to  NiCl2,  but  less than

                                          12-235

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 that  produced by CaCr04  (Heck  and Costa, 1982a).  Both  nickel  and chromium have been impli-
 cated  in the  etiology of  human  cancer (Costa,  1980).   These  results  thus  suggest that lead
 acetate  has effects  similar  to those caused by  other  metal  carcinogens.   In particular, the
 ability  of  lead acetate to  induce  neoplastic  transformation in  cells in a concentration-depen-
 dent manner is highly suggestive  of  potential  carcinogenic activity.  It should also be noted
 that lead acetate induced these transformations at concentrations that decreased cell survival
 by  only  27  percent (DiPaolo  et al.,  1978).   Further studies  from other laboratories utilizing
 the cell transformation assay and  other lead  compounds  are needed.

 12.7.3   Genotoxicity  of Lead
     Since  cancer  is  known to be  a  disease  of altered gene  expression, numerous studies have
 evaluated changes in  DMA consequent to exposure to suspected  carcinogenic agents.  The general
 response associated with  such alterations in regulation  of DMA function has been called geno-
 toxicity.   Various  assay systems  developed  to examine specific changes  in  DNA structure and
 function caused by  carcinogenic agents include assays  that  evaluate chromosomal aberrations,
 sister chromatid exchange,  mutagenicity,  and functional  and  structural  features of DNA meta-
 bolism.  Lead's effects on these parameters are discussed below.
 12.7.3.1  Chromosomal  Aberrations.   Two  approaches  have  been used  in  the analysis of effects
 of  lead  on  chromosomal  structure.  The first  approach involves  culturing  lymphocytes either
 from humans exposed to lead  or from  experimental animals given a certain dosage of lead. The
 second approach  involves exposing cultured   lymphocytes  directly  to lead.    For present pur-
 poses, emphasis will  not  be  placed on the type of  chromosomal  aberration induced, since most
 of the available studies  do  not appear to associate  any specific type of chromosomal aberra-
 tion with  lead exposure.    Little  is  known  of the significance of  chromosomal  aberrations  in
 relationship to cancer, except that in a number of instances  genetic diseases associated with
 chromosomal  aberrations often enhance the probability of neoplastic disease.  However, impli-
 cit in a morphologically distinct change in genetic structure is the possibility of an altera-
 tion in gene expression that  represents a salient feature of neoplastic disease.
     Contradictory reports exist regarding the induction of chromosomal aberrations in lympho-
cytes from  humans exposed  to  lead (Tables 12-21  and  12-22).   These studies have been grouped
 in two separate tables based  upon their  conclusions.   Those  studies reporting a positive ef-
fect of  lead  on chromosomal aberrations are  indexed in Table 12-21, whereas studies reporting
no association between lead exposure and chromosomal aberrations are  indexed in Table 12-22.
Unfortunately, these   studies  are difficult  to thoroughly evaluate  because of  many  unknown
variables (e.g., absence  of sufficient evidence of lead  intoxication,  no dose-response rela-
tionship, and  absence of  information regarding lymphocyte culture time).   To illustrate, in a

                                          12-236

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                               TABLE 12-21.   CYTOGENET1C INVESTIGATIONS OF CELLS FROM INDIVIDUALS EXPOSED TO LEAD:   POSITIVE STUDIES
Number of Cell
exposed Number of culture
subjects controls time, hr
8 14 ?
10 10 72
14 5 48
105 - 72
11 - 68-70
(before and after
exposure)
44 15 72
23 20 48
20 20 46-48
26 (4 low, not 72
16 medium, given
6 high ex-
posure)
12 18 48-72
Lead level in
blood, ug/dl,
or urine, ug/£
62-89
(blood)
60-100
(blood)
155-720
(urine)
11.6-97.4
mean, 37.7
(blood)
34-64
(blood)
30-75
(blood)
44-95
(not given)
53-100
(blood)
22.5-65
(blood)
24-49
(blood)
Exposed subjects
Workers in a lead
oxide factory
Workers in a chem-
ical factory
Workers in a zinc
plant, exposed to
fumes & dust of
cadmium, zinc &
lead
Blast-furnace work-
ers, metal grin-
ders, scrap metal
processers
Workers in a
lead- acid battery
plant and a lead
foundry
Individuals in a
lead oxide fac-
tory
Lead-acid battery
Belters, tin workers
Ceramic, lead, &
battery workers
Sue Her workers
Electrical storage
battery workers
Type of damage
Chromatid and
chromosome
Chromatid gaps,
breaks
Gaps, fragments,
exchanges, dicen-
trics, rings
"Structural ab-
normalities,"
gaps, breaks,
hyperploidy
Gaps, breaks,
fragments
Chromatid and
chromosome
aberrations
Di Gentries,
rings, fragments
Breaks, frag-
ments
Gaps, chroma-
tid and chro-
mosome aberra-
tions
Chromatid and
chromosome aberra-
tions
Remarks
Increase in
chronosonal damage
correlated with
increased ALA
excretion
No correlation with
blood lead levels
Thought to be caused
by lead, not cadmium
or zinc
No correlation with
ALA excretion or
blood lead levels
No correlation
with ALA-D activity
in red cells
Positive correlation
with length of expo-
sure
Factors other than
lead exposure may be
required for severe
aberrations
Positive correlation
with blood lead levels
Positive correlation
with blood lead levels

I
References
Schwanitz et al.
(1970)
Gath & Thiess
(1972)
Oeknudt et al.
(1973)
Schwanitz et al.
(1975)
Forni et al.
(1976)
Garza-Chapa
et al. (1977)
Deknudt et al.
(1977b)
Sarto et al.
(1978)
Nordenson et al.
(1978)
Forni et al.
(1980)
Source:  International Agency for Research on Cancer (1980), with codifications

-------
                         TABLE 12-22.   CYTOGEHETIC INVESTIGATIONS OF CELLS FROM INDIVIDUALS EXPOSED TO LEAD:   NEGATIVE STUDIES
NiMber of
exposed subjects
29


32


35
.*
j
j
3 24






9

30

NiMber of
control s
20


20


35


15






9

20

Cell culture
tine, hrs
46-48


46-48


45-48


48






72

4B

Blood lead
level , ug/dl
Not given, stated
to be 20-30%
higher than controls
Range not given;
highest level was
590 mg/1 [sic]
Control, <4; ex-
posed, 4 - >12

19.3 (lead)
0.4 (cadmium)





40 ± 5,
for 7 weeks
Control, 11.8-13.2;
exposed, 29-33
Exposed subjects
Policemen "permanently in
contact with high levels of
automotive exhaust"
Workers in lead manufacturing
industry; 3 had acute lead
intoxication
Shipyard workers employed as
"burners" cutting metal struc-
tures on ships
Mixed exposure to zinc, lead,
and cadmium in a zinc-smelting
plant; significant increase in
chromatid breaks and exchanges.
Authors suggest that cadmium
was the major cause of this
damage
Volunteers ingested capsules
containing lead acetate
Children living near a lead
smelter
References
Bauchinger et
(1972)

Schnid et al.


O'Riordan and
(1974)

Bauchinger et
(1976)






al.


(1972)


Evans


al.






Bulsw & De France
(1976)
Bauchinger et
(1977)

al.

Source:   International Agency for Research on Cancer (1980).

-------
number of the studies where lead exposure correlated with an increased incidence  of  chromosom-
al aberrations (Table  12-21),  lymphocytes were cultured for 72  hours.   Most cytogenetic  stu-
dies  have  been conducted  with  a maximum  culture time  of  48  hours to avoid  high  background
levels of chromosomal  aberrations  due to multiple cell  divisions  during  culture.   Therefore,
it  is  possible that the positive effects  of  lead on chromosomal aberrations  may require  the
longer culture period in order to be observed. Nonetheless,  it  is evident that in the negative
studies, the  blood  lead  concentration  was generally  lower than  in  the studies reporting  a
positive effect of  lead on chromosomal  aberrations, although  in many of the latter instances
blood  lead  levels  indicated severe exposure.   In some  of these positive studies there was  a
correlation  in the  incidence  of gaps,  fragments, chromatid exchanges,  and  other chromosomal
aberrations with blood  lead levels (Sarto et al., 1978; Nordenson et al., 1978).  However, as
indicated in  Table  12-21,  in other studies there were  no direct correlations between indices
of  lead  exposure (i.e.,  ALA excretion) and  numbers of chromosomal  aberrations.  Nutritional
factors  such  as  Ca2  levels HI  vivo  or iji vitro are also important since it  is possible that
the  effects  of  lead on  cells  may be  antagonized by  Ca2+ (Mahaffey, 1983;  Poirier etal.,
1984).   As  is usually the case  in  studies of human populations exposed  to  lead,  exposure to
other  metals  (zinc,  cadmium, and copper)  that  may produce  chromosomal aberrations was preva-
lent.   These studies  did  not attempt  to determine the specific lead  compound to which the
individuals were exposed.
      In  a  more recent study by  Form' et al.  (1980), 18 healthy  females occupationally exposed
to  lead  were evaluated for  chromosomal aberrations  in  their lymphocytes  cultured for 48 or 72
hours.   There were more aberrations at  the 72-hour culture  time  compared  with  the 48-hour cul-
ture  period  in both  control  and  lead-exposed  groups, but this  difference  was  not statistically
significant.   However, statistically significant differences  from  the 72-hour controls were
noted  in the 72-hour culture obtained  from the  lead exposed group.   These results  demonstrate
that  the extended  72-hour culture time  results  in  increased chromosomal  aberrations in the
control  lymphocytes and  that  the  longer culture  time  was  apparently necessary to detect the
effects  of  lead on  chromosomal  structure.   However, the blood  lead  levels  in the  exposed fe-
males  ranged from 24 to  59 (jg/dl,  while  control  females had blood lead levels ranging from  22
to  37 ug/dl.  The  small  effect  of  lead on chromosomal  aberration  may be  due to  the absence  of
sufficient  differences in the extent of  lead exposure.  Additionally, many  agents  that  induce
chromosomal  aberrations require  extended  time periods  for the  lesion to be expressed,  as  indi-
cated above for  lead.
      Some  studies  have also been  conducted  on the direct effect of soluble  lead salts on cul-
tured human lymphocytes.  In a  study  by Beek and Obe (1974), a longer (72-hr) culture time was
used and lead acetate was found  to  induce chromosomal  aberrations at 100 uM.  Lead acetate had
no  effect  on chromatid aberrations  induced with  X-rays  or alkylating  agents  (Beek and Obe,
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 1975).   In another study  (Deknudt  and Deminatti,  1978), lead acetate at  1  and  0.1 mM caused
 minimal  chromosomal aberrations.  Both cadmium chloride  (CdCl2) and zinc chloride (2nCl2) were
 more  potent than lead acetate  in  causing these changes; however, both CdCl2  and  ZnCl2 also
 displayed  greater toxicity than lead acetate.
      Chromosomal  aberrations  have  been  demonstrated  in lymphocytes from cynomolgus  monkeys
 treated  chronically with lead acetate  (6  mg/day, 6 days/week for 16 months),  particularly when
 they  were  kept on a low-calcium diet (Deknudt et al., 1977a). These aberrations accompanying a
 low-Ca2   diet  were  characterized by the  authors as  severe  (chromatid exchanges, dispiraliza-
 tion,  translocations,  rings, and polycentric chromosomes).   Similar  results were observed In
 mice  (Deknudt and Gerber,  1979).  The  effect of low calcium on chromosomal  aberrations  induced
 by  lead  could be due to interaction of Ca2  and Pb2  at the level of the chromosome  (Mahaffey
 1983).   Leonard  and  his  coworkers found  no effect of lead on the incidence of chromosomal ab-
 errations  in  accidentally  intoxicated  cattle (Leonard et al., 1974) or in  mice given 1 g Pb/i
 drinking water for 9 months  (Leonard et al., 1973).  However, Muro and Goyer (1969)  found gaps
 and chromatid  aberrations in  bone  marrow  cells  cultured for four days after  isolation from
 mice  that had been maintained on 1  percent dietary lead acetate for two  weeks.  Chromosomal
 loss  has been reported (Ahlberg et al., 1972) in Drosophila exposed to triethyl  lead (4 mg/1)
 but inorganic  lead had no effect (Ramel, 1973).   Lead acetate has also been shown  to induce
 chromosomal aberrations in cultured  cells other than  lymphocytes, viz. Chinese  hamster ovary
 cells  (Bauchinger and Schmid, 1972).
     These  studies demonstrate that under  certain conditions, lead compounds are  capable of
 inducing chromosomal  aberrations jm  vivo and in tissue  cultures.   The  ability of lead to in-
 duce  these  chromosomal changes  appears to be concentration-dependent and highly  influenced by
 calcium  levels.   In  lymphocytes  isolated from patients  or experimental   animals,  relatively
 long (72-hr) culture  conditions are required for the abnormalities to be expressed,  indicating
 a requirement  for cellular  processes  (e.g., DNA  repair) to  interact  with  the  hidden  lead-
 induced DNA lesions  to produce a morphologically manifested  aberration.
 12.7.3.2   Sister Chromatid Exchange.   Sister chromatid  exchange  affords  a means of visually
 assessing the normal  movement of DNA in the genome. The sister chromatid exchange assay offers
 a very  sensitive probe  for  the  effects of genotoxic  compounds on  DNA  rearrangement,  as  a
 number  of chemicals   with  carcinogenic  activity  are  capable  of increasing these  exchanges
 (Sandberg,  1982). The  effect of lead  on  such  movement has  been examined  in cultured  lympho-
cytes  (Beek and  Obe,  1975),  with no increase in exchanges observed  at lead acetate  concentra-
tions  of 0.01 mM.  Two more  recent studies have examined the effect of  human lead exposure on
the   incidence  of sister chromatid  exchange in  peripheral  blood lymphocytes (Dalpra  et al.
1983; Grandjean et al., 1983).  A  study by Dalpra et al. (1983)  involved  an investigation of
the  incidence of  sister chromatid  exchanges in 19  children  who lived in a  widely contaminated
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area and who showed Increased lead absorption.   Blood lead levels as well  as erythrocyte  ALA-D
activity and zinc protoporphyrin in blood were measured in the exposed group as  well  as  in  the
12 controls.  The  exposed group  had  blood lead  levels ranging  from  29.3 to  62.7  ug/dl  and
ALA-D activity  ranging  from 8 to 32  erythrocytes.   In contrast, the control group  had  blood
lead values  ranging from  10  to 21 ug/dl and  ALA-D  values ranging from 36 to  78/ml  erythro-
cytes.   Similarly,  zinc  protoporphyrin  ranged from 65 to 341 ug/dl in the mil/ml exposed  group
and from 9  to  38 ug/dl  in the controls.   Thus,  the  population  studied was well  defined with
regard to their exposure to lead.  Based  upon the measured parameters, the lead exposure  was
not severe.   The  results of an examination of sister chromatid exchange frequencies  indicated
no significant differences between the control group  and the lead-exposed group.  This appears
to be a well-conducted  study with excellent documentation of lead exposure in the population.
The study  examined the  same  exposed children that  were  observed by  Form'  et al.  (1981) in
their  study of  chromosomal aberrations.   Forni  et al.  (1981),  however,  found  an  increased
level of chromosomal aberration after 48- or 72-hr culture times (vide supra), suggesting that
chromosomal   aberrations  may  appear  in  the absence  of detectable sister  chromatid exchange
(Dalpra et al., 1983).   These findings emphasize the importance of utilizing a battery of test
systems with different  endpoints  to accurately comprehend the  true genotoxic potential  of an
agent.
     Another recent well-conducted  study, by  Grandjean  et al.  (1983),  examined the  incidence
of sister chromatid exchange in adult  lead-exposed  men.   There was a significant correlation
(p <0.001)  between  the  observed zinc protoporphyrin  levels  and the incidence of sister chro-
matid exchange  in the lead-exposed group.  However, there  was a  poor correlation between blood
lead levels and  sister  chromatid exchange,  which suggested that zinc protoporphyrin  levels
were a better indicator  of  lead exposure  than  blood  lead  levels  in this study.   Interestingly,
during  a  4-week  cessation of lead  exposure,  the elevated  incidence  of  sister chromatid ex-
change diminished,  together with  the zinc protoporphyrin  levels and blood  lead  levels in per-
fused blood lymphocytes.   The persistence of  the  sister  chromatid exchange depends to a large
extent  upon the proliferation  and  half-life of the  lymphocyte.   In  workers newly exposed to
lead for  four  months there were  clear  increases  in  lead  exposure  parameters  in  the  absence of
any  increase  in  the sister  chromatid  exchange  frequency.  Collectively,  this study  demon-
strates for the first time a  positive  correlation between  lead exposure  and sister chromatid
exchange.   Further, it  indicates  that  the  increased  sister chromatid  exchange  is  not rapid in
its  induction,  since it was only observed  in  lymphocytes after chronic exposure.  Additional-
ly, in lymphocytes  the increased  sister chromatid  exchange was  reversed when the lead exposure
was decreased.   It  should  be noted,  however,  that  these effects occurred  in only one cell  type
and  the  incidence of sister chromatid  exchange may  be  uniquely different for  every cell  type

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 jn  vivo.   Nevertheless,  these  results  support the potential injurious role  lead  may  have on
 chromosomal  structure  and function.
      The  ability of agents such as  lead  to cause abnormal rearrangements in the structure of
 DNA,  as revealed by the  appearance  of chromosomal aberrations and sister chromatid exchanges
 has  become an important  focus  in carcinogenesis research.  Current theories suggest that can-
 cer  may result from an abnormal expression of oncogenes (genes that code for protein products
 associated with  virally induced cancers).  Numerous oncogenes are  found  in normal human DMA
 but  the genes are regulated such that  they are not expressed in a carcinogenic fashion.   Re-
 arrangement  of these DMA sequences within the genome is associated with ontogenesis, although
 the  activation of  oncogenes  has not been  demonstrated to  be  the cause  of  tumor induction
 Evidence  has  been presented suggesting that chromosomal aberrations such as translocations are
 associated with  certain forms  of cancer  and with  the  movement of oncogenes in regions of the
 DNA  favoring their  expression  in  cancer  cells (Shen-Ong  et al., 1982).   By  inducing  aberra-
 tions  in  chromosomal structure, lead may  enhance the probability of an oncogenic event.
 12.7.3.3   Effects on  Bacterial and Mammalian Mutagenesis Systems.   Bacterial  and  mammalian
 mutagenesis  test systems  examine the  ability of  chemical  agents to  induce changes  in  DNA
 sequences  of  a specific gene product that is monitored by selection procedures.   They  measure
 the potential of a chemical agent to produce a change in DNA, but this change  is not likely to
 be  the same  alteration  in gene expression  that occurs  during  oncogenesis.   However,  if an
 agent  affects the expression  of a  particular  gene  product that is being monitored,  then It
 could  possibly affect  other  sequences that may result  in  cancer.   Since  many carcinogens are
 also  mutagens,  it is  useful  to employ  such systems  to  evaluate genotoxic  effects of lead.
     Use  of  bacterial  systems  for assaying metal genotoxicity must  await further development
 of bacterial  strains  that are  appropriately responsive to  known  mutagenic metals (Rosenkranz
 and Poirier,  1979;  Simmon,  1979;  Simmon et al., 1979;  Nishioka,  1975; Nestmann et al.,  1979).
 Mammalian  cell mutagenic  systems  that screen for specific alterations in  a defined gene muta-
 tion have  not been useful in detecting mutagenic activity with known carcinogenic metals (Heck
 and Costa, 1982b).   In  plants,  however,  chromosomal  aberrations in root tips  (Mukherji  and
Maitra, 1976)  and other mutagenic  activity, such as chlorophyll  mutations (Reddy and  Vaidya-
 nath, 1978) and reproductive organ mutations (Lower et  al., 1983), have been demonstrated  with
 lead.
12.7.3.4   Effects on  Parameters of DNA Structure and Function.   There  are a  number of  very
sensitive  techniques for  examining the  effect of metals on  DNA  structure and function in in-
tact  cells.   Although  these techniques  have  not  been extensively utilized  with respect  to
metal  compounds,  future research will probably be devoted to this  area.  Considerable work has
been done to understand the effects  of metals on enzymes involved  in DNA replication.

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     SI rover  and  Loeb  (1976)  examined  effects  of  lead  and other  metal  compounds upon  the
fidelity of replication  of  DNA by a viral  DNA polymerase.   High concentrations of metal  ions
(1n some cases in the millimolar range) were required to decrease the fidelity of replication,
but there  was a  good  correlation between  metal  ions that are carcinogenic  or  mutagenic  and
their activity in decreasing  the fidelity of DNA replication.   This assay system measures  the
ability of  a  metal  ion to incorporate  incorrect  (non-homologous)  bases using a defined poly-
nucleotide  template.   In an  intact cell, this would cause  the induction of a mutation if  the
Insertion  of  an   incorrect base  is phenotypically expressed.  Since  the  interaction  of metal
ions with  cellular  macromolecules  is  relatively unstable, misincorporation  of  a base during
semi-conservative DNA  replication  or during DNA repair synthesis following the induction of a
DNA lesion  with  a metal could alter the base sequence of the DNA in an intact cell.   Lead at
4 mM was among the  metals listed  as mutagenic or carcinogenic that  caused  a decrease in  the
fidelity of replication (Sirover and Loeb, 1976).   Other metals active in decreasing fidelity
included:   Ag+,  Be2*,   Cd2+,  Co2"1", Cr2+,  O3+,  Cu2+, Mn2+, and  Ni2+.   Metals that decreased
fidelity are  metals also  implicated as  carcinogenic or mutagenic  (Sirover and Loeb, 1976).
     In  a  similar  study,  Hoffman and  Niyogi  (1977) demonstrated  that lead chloride was the
most potent of 10 metals tested  in inhibiting RNA synthesis  (i.e., Pb2+ > Cd2+ >  Co2+ > Mn2+ >
L1+ >  Na  > K )   for both  types  of templates tested,  i.e.,  calf thymus DNA  and  T4 phage DNA.
These  results were  explained  in terms  of  the binding of these metal  ions  more to the bases
than to the phosphate  groups of  the DNA  (i.e., Pb2+  > Cd2+ > Zn2* >  Mn2* > Mg2+ >  Li+ = Na+ =
K+).   Additionally, metal compounds,  such as lead chloride, with carcinogenic or mutagenic
activity were found to stimulate mRNA chain initiation  at 0.1  mM concentrations.
     These  well-conducted mechanistic studies provide  evidence  that lead can affect a molecu-
lar process associated with normal  regulation of gene expression.   Although far removed  from
the  intact cell   situation,  these  effects  suggest  that lead  may  be genotoxic.  In a  related
study,  lead sulfate along with numerous  other toxic  and carcinogenic metals  was shown  to cause
an  S-phase specific cell cycle  block  (Costa et  al., 1982).   A  significant  effect of  lead was
observed at 20 \M.   These  results  indicate that  this metal  will  interfere with the normal  syn-
thesis and replication of DNA.   A recent study has  examined the  ability of  lead acetate to in-
duce  strand  breaks and DNA  repair synthesis in cultured  mammalian cells  (Robinson  et  al.,
1984).   Lead acetate  was  slightly more potent than NiCl2  in  inducing true  DNA  single  strand
breaks,  based upon neutral nucleoid  gradient analysis, but was  considerably less potent  than
CaCr04 or  HgCl2  (Robinson et al.,  1984).   Lead acetate  also caused  induction  of  DNA repair
synthesis   based  upon  analysis  with  CsCl equilibrium density  gradient sedimentation.   DNA
repair synthesis was  elevated  about  10-fold above the control level at  200 uM lead acetate
exposure for 1  hr  (Robinson  et al.,  1984).   These results  further  support the concept that
 lead  can have effects  upon the DNA.
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 12.7.4   Lead as an  Initiator and Promoter of Carcinogenesis
     An  agent  may act as a carcinogen in two distinct ways:  (1) as an initiator; or (2) as a
 promoter (Weisburger  and Williams, 1980).   By definition, an initiator must be able to inter-
 act with DNA to produce  a genetic  alteration, whereas a promoter acts in a way that allows the
 expression  of  an altered  genetic  change  responsible  for cancer.   Since  lead is  capable of
 transforming cells  directly  in culture and affecting DNA-to-DNA and ONA-to-RNA transcription,
 it may  have some initiating activity.  Its ability  to  induce chromosomal  aberrations is also
 indicative  of  initiating activity.  The ability of lead to induce proliferation in the kidney
 as indicated by  increased DNA, RNA, and protein synthesis suggests that it may also have pro-
 moting activity in cancer target tissues (Choie and Richter, 1974a,b).   Its similarity to Ca2+
 suggests that  it  may alter regulation of this cation in processes (e.g., cell growth) related
 to promotion (see Section 12.3.5).  A recent study, demonstrating that subsequent administra-
 tion  of basic  lead acetate greatly  enhances  the  development of renal  tubular  cell  tumors in
 rats  previously  treated with  n-ethyl-n-hydroxyethylnitrosamine,  indicates  a  promotional  role
 of this  agent  as well (Hiasa  et al.,  1983).   Thus,  evidence is accumulating  to  suggest that
 lead  and its  compounds  are  complete  carcinogens  possessing  both initiating and  promoting
 activity.

 12.7.5   Summary and Conclusions
     It  is  evident  from  studies reviewed above that, at  relatively high concentrations, lead
 displays  some  carcinogenic activity  in  experimental animals  such as the  rat.   Lead  may act
 either  as an  initiator  or  promoter of  carcinogenic activity,  because  it  has  genotoxic pro-
 perties  related to  cancer initiation,  as well  as  cellular effects related  to  the  promotion or
 expression  of  cancer.   The presence of  intranuclear  lead inclusion bodies in  the  kidney may
 pertain  to  lead's carcinogenic effects,  since both the formation  of these bodies and the in-
 duction  of tumors occur at relatively high doses of lead.   Evidence exists  for the presence of
 these inclusion bodies  in  kidneys  from experimental  animals treated with lead and also in one
well  documented  human case report of renal  cancer  associated with excessive  lead  exposure.
The interaction of  lead  with  key  non-histone chromosomal  proteins  in  the  nucleus to form the
 inclusion bodies  or the  presence  of inclusion  bodies  in  the nucleus may alter genetic  func-
tion,  thus  leading  to  cell  transformation.   Obviously,  elucidating the mechanism  of lead car-
cinogenesis  requires  further  research efforts  and  only theories can  be formulated  regarding
its oncogenic action at present.
     It  is  hard to  draw clear conclusions concerning what role  lead may play  in the induction
of human neoplasia.   Epidemiological  studies  of  lead-exposed  workers provide no  definitive
findings.   However,  statistically  significant  elevations  in respiratory tract and  digestive
system cancer  in  workers exposed  to lead and other  agents warrant concern.   Also,  since lead
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acetate can  produce  renal  tumors  in some  experimental  animals,  it may be  prudent  to assume
that  lead  compounds  may be  carcinogenic  in  humans,  as was  concluded by  the  International
Agency for  Research  on  Cancer  (1980).    However,  this statement is qualified by  noting that
lead  has  been observed  to  increase tumorigenesis  rates in  animals  only at  relatively high
concentrations, and therefore it does not appear to be a potent carcinogen.  A recent epidemi-
ological  study  and two  case  reports suggest  the possible association of lead  exposure with
the induction of  kidney  tumors  in humans;  however, several other epidemiological studies have
not thus  far demonstrated  a  significant excess  of kidney tumors  in  lead workers.   In vitro
studies further  support  the genotoxic  and  carcinogenic role of  lead,  but also  indicate that
lead is not potent in these systems either.
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 12.8  EFFECTS  OF  LEAD ON THE  IMMUNE SYSTEM
 12.8.1  Development  and Organization of the  Immune System
      Component cells of the  immune system arise  from a pool of pluripotent stem cells in the
 yolk sack and liver of the developing  fetus and in the bone marrow  and spleen of the adult.
 Stem cell  differentiation  and maturation follows one of several lines to produce lymphocytes
 macrophages, and  polymorphonuclear leukocytes.  These cells have important roles in immunolog-
 ical  function  and host defense.
      The predominant lymphocyte  class  develops in the thymus, which is derived from the third
 and  fourth pharyngeal  pouches at 9 weeks of gestation  in man (day 9 in mice).  In the thymus
 microenvironment, they  acquire characteristics of thymus-derived  lymphocytes  (T-cells),  then
 migrate  to peripheral  thymic-dependent  areas  of  the  spleen  and  lymph nodes.   T-cells  are
 easily distinguished from  other  lymphocytes  by genetically  defined cell  surface markers  that
 allow them to be  further subdivided  into  immunoregulatory  helper  and suppressor  T-cells.
 T-cells  also  participate  directly  as  cytolytic effector cells against  virally infected  host
 cells, malignant  cells, and foreign tissues,  as well  as in delayed-type hypersensitivity (DTH)
 reactions  where they elaborate lymphokines  that modulate the inflammatory  response.   T-cells
 are  long-lived lymphocytes and are not readily replaced.   Thus, any loss or injury to T-cells
 may  be detrimental  to the host and may  result in increased susceptibility to viral,  fungal
 bacterial, or parasitic diseases.   Individuals with acquired immune deficiency syndrome (AIDS)
 are  examples of  individuals with  T-cell  dysfunction.  There  is  ample evidence that depletion
 by environmental  agents  of thymocytes  or stem cell  progenitors  during lymphoid organogenesls
 can produce permanent immunosuppression.
      The  second major  lymphocyte  class  differentiates from  a lymphoid  stem-cell  in a yet un-
 defined  site  in  man, which would correspond  functionally  to the Bursa of Fabricius  in avian
 species.    In man, B-lymphocyte maturation and differentiation  probably  occur  embryologically
 in gut-associated lymphoid tissue  (GALT)  and fetal  liver,  as  well  as adult  spleen  and  bone
 marrow.  This  is  followed  by  the peripheral  population of  thymic-independent  areas of spleen
 and lymph nodes.   Bone marrow-derived lymphocytes (B-cells), which mature independently of the
 thymus,  possess, specific  immunoglobulin  receptors  on their  surfaces.   The presence  of  cell
 surface  immunoglobulin  (slg)  at  high density is the major  characteristic  separating  B-cells
 from  T-cells.   Following  interaction with  antigens  and subsequent activation,  B-lymphocytes
proliferate  and  differentiate into  antibody-producing  plasma cells.   In contrast  to  the
 long-lived  T-cell,   B-cells  are   rapidly  replaced   by  newly   differentiating  stem  cells.
Therefore,  lesions  in the B-cell  compartment may be less  serious than those  in  the T-cell
compartment since they  are   more  easily reversed.   Insult to  B-cells at the stem  cell  or
terminal  maturation  stage  can result in  suppression of specific immunoglobulin  and  enhanced
susceptibility to infectious agents whose  pathogenesis is  limited by antibodies.
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     Pluripotent stem  cells  also give rise  to lymphocytes whose lineages are  still  unclear.
Some possess natural cytolytic  activity  for tumor cells (natural  killer cell  activity), while
others, devoid of T- and  B-cell surface markers  (null  cells),  participate in antibody-depen-
dent cell-mediated cytotoxicity  (ADCC).   The pluripotent stem cell  pool also  contains precur-
sors of  monocyte-macrophages  and polymorphonuclear  leukocytes (PMN).   The  macrophage has  a
major  role  in  presentation and  processing  of  certain antigens, in cytolysis of  tumor target
cells,  and  in  phagocytosis  and  lysis of persistent  intracellular  infectious  agents.  Also,  it
actively phagocytizes and kills  invading organisms.  Defects in differentiation or function  of
PMNs or macrophages predispose the host to infections by bacteria and other agents.
     This introduction should make  it evident that  the effects of an element such as lead  on
the  immune  system may be expressed  in  complex or subtle  ways  (see also Section 12.3.5.3.5).
In  some  cases, lead might  produce  a lesion  of  the immune  system not resulting in markedly
adverse  health  effects,  especially  if the lesion did not  occur at  an early stem cell stage  or
during  a critical  point  in  lymphoid  organogenesis.   On  the other hand,  some lead-induced
immune  system  effects  might adversely  affect  health through  increasing susceptibility  to
infectious  agents  or  neoplastically  transformed cells  if, for example,  they  were to impair
cytocidal or bactericidal function.

12.8.2   Host Resistance
     One  way of ascertaining  if a  chemical  affects  the   immune response of an animal  is  to
challenge an exposed animal with a pathogen  such  as  an  infectious agent or oncogen.   This pro-
vides  a  general approach to determine  if  the  chemical   interferes with  host immune defense
mechanisms.  Host defense is a  composite of  innate immunity,  part of which is phagocyte activ-
ities, and  acquired immunity,  which  includes  B-  and T-lymphocyte and enhanced  phagocyte reac-
tivities.   Analysis of host resistance constitutes a holistic approach.  However, dependent on
the choice  of the  pathogen,   host  resistance  can  be  evaluated  somewhat  more selectively.
Assessment  of  host resistance  to   extracellular microbes such  as Staphylococci,  Salmonella
typhimurium, Escherichia  coli,  or Streptococcus  pneumoniae and to  intracellular organisms such
as  Listen'a monocytogenes or Candida albicans primarily measures  intact  humoral  immunity  and
cell-mediated   immunity,  respectively.    Immune   defense  to  extracellular  organisms  requires
T-lymphocyte,  B-lymphocyte,  and macrophage  interactions  for  the production  of specific anti-
bodies to  activate the  complement  cascade  and  to  aid   phagocytosis.   Antibodies  can also
directly neutralize some  bacteria and viruses.  Resistance to intracellular organisms requires
T-lymphocyte and  macrophage interactions  for T-lymphocyte  production of lymphokines, which
 further  enhance immune mechanisms  including macrophage bactericidal activities.  An additional
T-lymphocyte  subset,  the  cytolytic  T-cell,  is involved  in resistance  to tumors;  immune
 defenses against  tumors  are also aided  by NK- and K-lymphocytes and macrophages.
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 12.8.2.1  Infectivity Models.   Numerous studies  designed to  assess  the  influence of lead on
 host resistance  to  infectious agents  consistently  have shown  that  lead impairs host resis-
 tance,  regardless of whether the  defense mechanisms  are  predominantly dependent on humoral- or
 cell-mediated immunity (Table  12-23).
              TABLE  12-23.   EFFECT  OF  LEAD ON  HOST  RESISTANCE TO  INFECTIOUS AGENTS
Species
Mouse
Rat
Rat
Mouse
Mouse
Mouse
Mouse
Infectious agent
S. typhimurium
E. coli
S. epidermidis
L. monocytogenes
EMCt virus
EMC virus
Langat virus
Lead dose
200 ppm
2 mg/100 g
body weight
2 mg/100 g
body weight
80 ppm
2000 ppm
13 ppm


50 mg/kg
body weight
Lead exposure
i.p.
i.v.
i.v.
oral
oral
oral
oral
9
5
iy
iy
iy
iy
30 days
1 day
1 day
; 4 wk
; 2 wk
; 10 wk
; 2 wk
Mortality*
54%
96%
80%
100%
100%
80%
68%
(13%)
(0%)
(0%)
(0%)
(19%)
(50%)
(0%)
Reference
Hemphil
Cook et
Cook et
1 et al. (1971)
al. (1975)
al
. (1975)
Lawrence (1981a)
Gainer (1977b)
Exon et
al
Thind and
. (1979)
Khan (1978)
The percent mortality is reported for the lowest dose of lead in the study that significantly
 altered host resistance. The percent mortality in parentheses is that of the non-lead-treated,
 infected control group.
tEMC = encephalomyocarditis virus.

     Mice (Swiss Webster)  injected i.p.  for 30 days  with 100 or 250 ug  (per 0.5 ml) of lead
nitrate and  inoculated  with Salmonella typhimurium had  higher mortality  (54 and 100 percent,
respectively) than non-lead-injected mice (13 percent) (Hemphill  et al., 1971).  These concen-
trations of  lead,  by themselves, did not produce any apparent toxicity.  Similar results were
observed in  rats acutely exposed to lead (one  i.v.  dose of 2 mg/100 g body weight) and chal-
lenged with  Escherichia  coli  (Cook et al.,  1975).   In  these two studies, lead could have in-
terfered with the  clearance of endotoxin from  the  S^ typhimurium or E. coli. and the animals
may have died  from endotoxin shock, and not septicemia, due to the lack of bacteriostatic or
bactericidal activities.    However,  the  study  by  Cook  et  al.   (1975)  also included  a  non-
endotoxin-producing  gram-positive  bacterium,  Staphylococcus  epidermidis,  and  lead  still
impaired host  resistance.   In  another study,  lead  effects on host resistance  to  the intra-
cellular parasite  Listen'a  monocytogenes were monitored (Lawrence,  1981a).   CBA/J mice orally
exposed to  16,  80,  400,  and 2000  ppm lead  for  four weeks were assayed for viable Listerja
after 48 and 72 hours, and for mortality after 10 days.   Only 2000 ppm lead  caused significant
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inhibition of early bactericidal  activity (48-72 hr), but 80-2000  ppm  lead produced  100 per-
cent mortality, compared with  0  percent mortality in the 0-16 ppm lead  groups.   Other reports
have suggested that  host  resistance is impaired  by  lead exposure of rodents.  Salaki et  al.
(1975) indicated that  lead  lowered resistance of mice to Staphylococcus aureus,  Listen'a,  and
Candida, and observed  higher  incidence of inflammation of the salivary  glands in lead-exposed
rats (Grant  et al.,  1980)  may be  due,  in part, to  lead-induced  increased susceptibility to
infections.
     Inhalation  of  lead  has also been reported  to  lower  host  resistance  to  bacteria.
Schlipkb'ter  and  Frieler (1979) exposed NMRI  mice to an aerosol of  13-14  ug/m3  lead  chloride
and clearance of Serratia marcesens in the lungs was reduced significantly.  Microparticles of
lead in  lungs  of mice were also  shown to lower  resistance to  Pasteurella multocida,  in  that
6 ug of  lead increased the percentage  of  mortality by 27 percent (Bouley et al., 1977).
     Lead  has also been shown  to  increase host susceptibility to viral  infections.  CD-I mice,
administered 2,000 and 10,000  ppm lead in drinking water for two weeks  and  subsequently inocu-
lated with encephalomyocarditis (EMC)  virus,  had  a significant  increase in  mortality (100 per-
cent at  2,000 ppm; 65 percent  at  10,000 ppm)  compared with control  EMC  virus-infected mice (13
percent)  (Gainer,  1977b).   In another study  (Exon  et al., 1979),  Swiss Webster mice were ex-
posed  to 13, 130, 1300, or 2600  ppm lead for 10  weeks  in their drinking water and were infec-
ted with EMC virus.  Although  as  low as 13 ppm lead  caused a  significant increase in mortality
(80  percent) in  comparison with  the  non-lead-treated  EMC  virus-infected mice (50 percent),
there were no dose-response effects, in that  2600 ppm lead resulted in  only 64 percent mortal-
ity.   The lack  of a  dose-response relationship in  the two  studies with EMC virus  (Gainer,
1977b;  Exon et  al.,  1979) suggests  that the  higher doses  of lead may directly inhibit EMC
Infectivity  as well  as host  defense mechanisms.   Additional studies have  confirmed  that  lead
inhibits host  resistance  to viruses.   Mice  treated  orally with lead nitrate (10-50 mg/kg/  day)
for  two weeks had suppressed  antibody titers to Langat virus (Type B arbovirus)  and  increased
titers of the  virus  itself  (Thind and  Singh,  1977),  and the  lead-inoculated, infected mice had
higher mortalities (25 percent at 10 mg/kg;  68 percent at 50 mg/kg) than the non-1ead-infected
mice (0 percent) (Thind and Khan, 1978).
      The effects of lead on  bacterial and viral infections  in humans  have never been studied
 adequately;  there  is  only suggestive evidence  that  human  host resistance  may be  lowered  by
 lead.   Children  with  persistently high  blood  lead levels  who  were  infected with  Shigella
 enteritis had  prolonged  diarrhea  (Sachs,  1978).   In  addition,  lead  workers with  blood  lead
 levels  of 22-89  ug/dl  have been reported to have more colds and influenza infections per year
 (Ewers  et al.,  1982).   This  study also indicated that secretory  IgA levels  were suppressed
 significantly in  lead  workers with a median blood lead level of 55 ^g/dl.   Secretory IgA is a
 major  factor  in immune  defense  against respiratory as well  as gastrointestinal infections.
                                           12-249

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     Hicks  (1972)  points out that  there  is  need  for  systematic epidemiological studies on the
 effects  of  elevated lead levels  on the incidence of infectious diseases in humans.  The cur-
 rent paucity of information precludes  formulation of any clear dose-response relationship for
 humans.   Epidemiological  investigations may  help  to determine if lead alters the immune system
 of man and  consequently  increases susceptibility  to infectious agents and neoplasia.
 12.8.2.2  Tumor Models and Neoplasia.   The  carcinogenicity  of lead has been studied both as a
 direct  toxic effect  of  lead (see  Section  12.7) and as a  means  of  better understanding the
 effects of  lead on  the body's defense mechanisms.  Studies by Gainer (1973, 1974) demonstrated
 that  exposure of CD-I mice  to  lead acetate potentiated the  oncogenicity of  a challenge with
 Rauscher  leukemia  virus  (RLV),  resulting in enhanced splenomegaly and higher virus titers in
 the spleen  presumably through an  immunosuppressive mechanism.  Recent studies by Kerkvliet and
 Baecher-Steppan  (1982)  revealed  that  chronic  exposure  of C57BL/6 mice  to lead  acetate  in
 drinking  water  at  130-1300  ppm enhanced  the growth  of primary tumors induced by Moloney sar-
 coma  virus  (MSV).   Regression  of MSV-induced  tumors  was not prevented by  lead  exposure, and
 lead-treated  animals   resisted  late sarcoma development following primary  tumor  resistance.
 Depressed  resistance  to  transplantable MSV tumors was associated with  a reduced  number  of
 macrophages, which  also exhibited reduced phagocytic  activity.
     In addition to enhancing the  transplantability  of tumors or the oncogenicity of leukemia
 viruses,  lead  has  also been shown  to facilitate the  development of chemically induced tumors.
 Kobayashi and Okamoto  (1974) found that intratracheal dosing of benzo(a)pyrene (BaP) combined
 with lead oxide  resulted in an increased frequency of lung adenomas and adenocarcinomas over
 hamsters  exposed to BaP  alone.   Similarly,  exposure  to lead acetate enhanced the formation of
 N(4'-fluoro-4-biphenyl) acetamide-induced renal  carcinomas  from 70 to 100 percent and reduced
 the latency to  tumor  appearance (Hinton  et  al.,  1980).   Recently, Koller et al.  (1985) found
 that exposure to lead (2600 ppm  in drinking water)  for 18 months  increased  the  frequency  of
 tumors, predominantly  renal  carcinomas,  in rats.  Similarly,  Schrauzer  et  al.  (1981) found
 that adding lead at 5 ppm to drinking  water of C3H/St mice infected with Bittner milk factor
 diminished  the  uptake of selenium  and reduced its anticarcinogenic effects,  causing mammary
 tumors  to  appear at  the same  high incidence  as  in  selenium-unsupplemented  controls.   Lead
 likewise significantly accelerated tumor growth and shortened survival  in this model.
     The  above  studies  on   host  susceptibility  to   various  pathogens,  including  infectious
 agents and  tumors,  indicate  that lead could be detrimental to health by methods other than di-
 rect toxicity.  In order to  understand the mechanisms by which lead suppresses host resistance
maintained  by phagocytes, humoral  immunity, and/or cell-mediated  immunity,  the  immune system
must be dissected  into its  functional components and the effects  of lead on each, separately
and combined, must  be  examined  in  order  that  the mechanism(s)  of the immunomodulatory poten-
tial  of lead can be understood.
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12.8.3    Humoral  Immunity
12.8.3.1  Antibody liters.   A low antibody 'titer  in animals  exposed  to  lead  could explain the
increased  susceptibility  of  animals  to extracellular  bacteria and  some  viruses  (see Table
12-24),  as well  as  to  endotoxins  (Selye  et  al.,  1966;  Filkins,  1970;  Cook  et  al., 1974;
Schumer  and  Erve,  1973;  Rippe  and Berry,  1973; Truscott,  1970).   Specific antibodies can
directly neutralize pathogens, activate  complement components to induce lysis,  or directly  or
indirectly enhance phagocytosis  via Fc or C3 receptors, respectively.  Studies  in animals and
humans  have  assayed the  effects of lead  on serum  immunoglobulin  levels,  specific  antibody
levels,  and complement  levels.   Analysis of serum immunoglobulin levels is not  a good measure
of  specific  immune reactivity,  but it  would  provide evidence for  an  effect on B-lymphocyte
development.

                         TABLE 12-24.  EFFECT OF  LEAD ON ANTIBODY TITERS
 Species
     Antigen
Lead dose and
  exposure
  Effect on
antibody titer
Reference
  Rabbit     Pseudorabies virus
  Rat        S.  typhimurium
                         2,500 ppm;  10 wk
                       Decrease    Koller (1973)
                         5,000-20,000 ppm; 3 wk    Decrease    Stankovic and Jugo
                                                                 (1976)
  Rat
Bovine serum albumin     10-1,000 ppm; 10 wk
  Mouse     Sheep erythrocytes
                         0.5-10 ppnT; 3 wk
                       Decrease    Koller et al.
                                     (1983)
                       Decrease    Blakley et al.
                                     (1980)
 aLead was administered as  tetraethyl  lead;  other studies used inorganic forms.

      Lead  had  little  effect  on  the serum  immunoglobulin  levels in  rabbits  (Fonzi et  al.,
 1967a),  children  with  blood  lead  levels   of  40 ug/dl  (Reigart and  Graber,  1976), or  lead
 workers  with  22-89 ug/dl   (Ewers  et al., 1982).  On  the other hand,  most  studies  have  shown
 that lead significantly impairs antibody production.  Acute oral lead exposure (50,000 ppm/kg)
 produced a decreased  titer of anti-typhus  antibodies in rabbits immunized with typhus vaccine
 (Fonzi et al., 1967b).  In  New Zealand white rabbits challenged with pseudorabies virus, lead
 (oral  exposure  to 2500 ppm for  70  days)   caused a 9-fold decrease in  antibody  titer  to the
 virus  (Koller,  1973).  However,  lead has  not  always  been  shown to  reduce  titers to virus.
 Vengris  and  Mare  (1974) did not  observe depressed  antibody titers to Newcastle  disease virus
 in  lead-treated  chickens, but their  lead  treatment was only  for  35  days prior  to  infection.
 Lead-poisoned  children also  had  normal  anti-toxoid  titers after booster  immunizations with
                                           12-251

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tetanus  toxoid  (Reigart and Graber, 1976).   In another study, Wistar rat dams were exposed to
5,000,  10,000,   or 20,000  ppm lead for  20  days  following  parturition (Stankovic  and  Jugo,
1976).   The  progeny were weaned at  21  days of age and given  standard  laboratory  chow for an
additional  month.   At  that time,  they were injected with  Salmonella  typhimurium.  and  serum
antibody titers  were assessed.  Each dosage  of lead resulted in significantly reduced antibody
titers.   More recently, rats  (Sprague-Dawley)  given  10  ppm lead acetate orally for 10  weeks
had  a significant  suppression in  antibody  titers  when challenged with bovine  serum albumin
(BSA)  and  compared with USA-immunized non-lead-exposed rats  (Keller  et al.,  1983).   Develop-
ment  of  a highly sensitive, quantitative,  enzyme-linked immunosorbent  assay  (ELISA) contrib-
uted  to detecting the immunosuppressive activity of lead at this dosage.
      Tetraethyl  lead also has  been responsible for reduced antibody titers in Swiss-cross mice
(Blakley et al., 1980).   The mice were exposed orally to 0.5, 1.0, and 2.0 ppm tetraethyl lead
for  3 weeks.  A significant  reduction in  hemagglutination titers to  sheep red  blood  cells
(SRBC) occurred  at all  levels  of exposure.
12.8.3.2   Enumeration of Antibody Producing  Cells (Plaque-Forming Cells).  From  the  above re-
sults, it  appears that  lead inhibits antibody production.   To evaluate this possible effect at
the cellular  level, the influence of lead on the number of antibody-producing cells after pri-
mary  or  secondary  immunization can be assessed.  In  primary humoral  immune responses (mostly
direct),  IgM plaque-forming  cells  (PFC)  are  measured,  whereas  in  secondary  or anamnestic
responses  (mostly  indirect),  IgG  PFC are  counted.  The primary  immune  response represents an
individual's  first  contact with a  particular antigen.   The  secondary  immune  response repre-
sents  re-exposure  to  the  same antigen weeks, months,  or even years after the primary antibody
response  has subsided.    The  secondary immune response is  attributed  to persistence,  after
initial contact  with  the  antigen,  of a substantial number  of antigen-sensitive memory cells.
Impairment of the  memory  response,  therefore, results in serious impairment of humoral immun-
ity in the host.
     Table 12-25 summarizes the effects of  lead on IgM or  IgG PFC development.   Mice exposed
orally to  tetraethyl lead (0.5, 1,  or 2 ppm) for three weeks exhibited a significant reduction
in the development  of  IgM and IgG PFC  (Blakley  et  al.,  1980).  Mice (Swiss Webster) exposed
orally to  13, 137,  or 1375 ppm inorganic  lead for  eight weeks had reduced numbers of IgM PFC
in each  lead-exposed  group (Keller and Kovacic,  1974).   Even the lowest lead group (13 ppm)
had a decrease.   The secondary response (IgG PFC, induced by a second  exposure to antigen SRBC
seven days after the  primary immunization) was inhibited to a greater extent than  the primary
response.  This  study indicated that chronic exposure to lead produced  a significant decrease
in the development  of  IgM PFC and IgG  PFC.   When Swiss  Webster mice  were  exposed  to 13, 130,
and 1300 ppm  lead  for 10 weeks and hyperimmunized by  SRBC injections  at week 1,  2, and 9, the

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         TABLE 12-25.  EFFECT OF LEAD ON THE DEVELOPMENT OF ANTIBODY-PRODUCING CELLS
Species
Mouse
Mouse
Mouse
Mouse
Mouse
Rat
Antigen*
SRBC (in vivo)
SRBC On vivo)
SRBC (in vivo)
SRBC (in vivo)
SRBC (in vivo)
SRBC (Tn vTtro + 2-ME)
SRBC (in vivo)

Lead dose and exposure
13-1370 ppm; 8 wk
0.5-2 ppm tetraethyl lead;
3 wk
13-1370 ppm; 10 wk
4 mg (i.p. or orally)
16-2000 ppm; 1-10 wk
16-80 ppm; 4 wk
2000 ppm; 4 wk
25-50 ppm; pre/postnatal
Effectt
IgM PFC (D)
IgG PFC (D)
IgM PFC (D)
IgG PFC (D)
IgG PFC (D)
IgM PFC (I)
IgG PFC (D)
IgM PFC (N)
IgM PFC (I)
IgM PFC (D)
IgM PFC (D)
Reference
Keller and
Kovacic
(1974)
Blakley et al .
(1980)
Koller and
Roan (1980a)
Koller et al .
(1976)
Lawrence
(1981a)
Luster et al .
(1978)
 Mouse
 Mouse
SRBC (in vitro)
SRBC (Tri vvtro + 2-ME)
50-1000 ppm; 3 wk
50-1000 ppm; 3 wk
SRBC (iji vitro + 2-ME)   2-20 ppm (in vitro)
IgM PFC (D)
IgM PFC
  (N or I)

IgM PFC (I)
Blakley and
  Archer (1981)
                                          Lawrence
                                            (1981b,c)
*The antigenic challenge with sheep red blood cells (SRBC) was in vivo or in vitro after in
 yiyo exposure to lead unless otherwise stated.   The jjn vitro assays were performed in the
 presence or absence of 2-mercaptoethanol (2-ME).

tlgM/G PFC = immunoglobulin M/G plaque-forming cells; D = decreased response; N = unaltered
 response; I = increased response.


memory response  as  assessed by the enumeration of IgG PFC was significantly inhibited at 1300

ppm  (Keller and  Roan,  1980a).  This  suggests  that  the  temporal  relationships  between lead

exposure  and  antigenic  challenge  may be critical.  Other studies support this interpretation.

Female Sprague-Dawley rats  with  pre- and  post-natal  exposure  to  lead (25 or  50 ppm) had a
significant  reduction  in  IgM  PFC (Luster  et  al.,  1978).   In  contrast,  CBA/J  mice exposed

orally to 16-2000  ppm  lead for  1-10 weeks  did not have  altered IgM  PFC responses to SRBC

(Lawrence,  1981a).  Furthermore, when Swiss  Webster mice were  exposed  to an acute  lead  dose  (4

mg  lead  orally or  i.p.),  the  number  of IgG  PFC  was  suppressed,  but  the number  of IgM  PFC was
enhanced  (Koller  et al., 1976).
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     The influence of  lead  on the development of  RFC  in mice was assessed further by iji vivo
exposure to lead,  removal  of spleen cells, and jn vitro analysis of RFC development.   Initi-
ally it appeared  that  low doses of lead (16 and 80 ppm) enhanced development,  and only a high
dose (2000  ppm)  inhibited  the  development of  IgM RFC  (Lawrence,  1981a).   However,  a  later
study by Blakley  and  Archer (1981) indicated that 50-1000 ppm lead consistently inhibited IgM
RFC.  Through the  analysis  of mixed cultures of  lead-exposed  lymphocytes  (nonadherent cells)
and unexposed macrophages  (adherent  cells),  and vice versa, as  well  as of ±n  vitro responses
to  antigens  that do not  require  macrophage  help (i.e.,  lipopolysaccharide, IPS),  their data
indicated that the effects  of lead may be at the level  of  the macrophage.   This was substan-
tiated by the fact that 2-mercaptoethanol (2-ME), a compound that can substitute for at least
one macrophage activity,  was  able to reverse the inhibition by lead.   This may explain why rn
vivo lead exposure (16  and 80 ppm) appeared  to  enhance the in vitro IgM RFC responses in the
study by  Lawrence  (1981a),  because 2-ME was  present  in the j_n vitro  assay  system.   Further-
more, ui vitro exposure to lead (2 or  20  ppm)  in spleen cell  cultures with 2-ME enhanced the
development of IgM RFC (Lawrence,  1981b,c).
     These  experiments  indicate  that  lead  modulates  the  development  of  antibody-producing
cells as well as  serum antibody titers, which supports the notion that lead can suppress hu-
moral immunity.   However,  it  should  be noted that the dose and route of exposure of both lead
and antigen may  influence the modulatory effects of lead.  The adverse effects of lead on hu-
moral  immunity  may be due  more   to  lead's   interference  with macrophage antigen  processing
and/or antigen presentation to lymphocytes  than  to  direct effects  on B-lymphocytes.   These
mechanisms require further investigation.

12.8.4    Cell-Mediated Immunity
12.8.4.1  Delayed-Type Hypersensitivity.   T-lymphocytes (T-helper and T-suppressor cells) are
regulators of humoral  and cell-mediated immunity as well as effectors of two aspects of cell-
mediated  immunity.   T-cells  responsive to delayed-type  hypersensitivity  (DTH)  produce lym-
phokines that  induce  mononuclear  infiltrates and activate macrophages, which  are  aspects of
chronic inflammatory  responses.    In  addition,  another subset of T-cells,  cytolytic T-cells,
cause direct lysis of  target cells (tumors or antigenically modified autologous cells) when in
contact with the  target.  To date, the effects of lead on cytolytic T-cell  reactivity have not
been measured, but the influence  of  lead  on inducer T-cells  has been studied (Table 12-26).
Groups  of  mice  injected i.p.  daily  for  30 days with  13.7-137 ppm  lead  were subsequently
sensitized i.v. with  SRBC.  The DTH reaction was suppressed in these animals in a dose-related
fashion (MUller et al., 1977).  The secondary DTH response was inhibited in a similar fashion.
In  another  study  (Faith  et al.,   1979),  the  effects  of chronic  low-level pre- and postnatal
lead exposure on  cellular immune   functions in Sprague-Dawley rats were assessed.  Female rats
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                    TABLE  12-26.   EFFECT  OF  LEAD  ON  CELL-MEDIATED  IMMUNITY
Species
Mouse
Rat
Mouse
Mouse
Lead dose and exposure
13.7-137 ppm; 4 wk
25-50 ppm; 8 wk
13-1300 ppm; 10 wk
16-2000 ppm; 4 wk
Parameter*
DTH
DTH
MLC
MLC
Effect
Decrease
Decrease
None
Decrease
Reference
Muller et al. (1977)
Faith et al. (1979)
Keller and Roan (19805)
Lawrence (1981a)
*DTH - delayed-type hypersensitivity;  MLC = mixed lymphocyte culture.

were  exposed  to 25  or  50 ppm lead acetate  continuously for seven weeks  before  breeding  and
through gestation  and lactation.   The progeny were weaned at three weeks of age and continued
on the respective lead exposure regimen of their mothers for an additional 14-24 days.   Thymic
weights and DTH responses were  significantly decreased by both  lead  dosages.   These  results
Indicate that chronic low levels of lead suppress cell-mediated immune function.
      The jn vitro  correlate  of the analysis of DTH responsive T-cells jn vivo is the analysis
of mixed lymphocyte culture (MLC) responsive T-cells.  When two populations of allogeneic lym-
phoid cells are cultured together, cellular interactions provoke blast cell transformation and
proliferation  of  a portion of the  cultured  cells (Cerottini and  Brunner,  1974;  Bach  et al.,
1976).  The response can  be made  one-way by irradiating one  of the  two allogeneic prepara-
tions,  in  which case the irradiated  cells are the stimulators (allogeneic B-cells and macro-
phages) and the responders (T-cells)  are  assayed for their proliferation.  The  mixed lympho-
cyte reaction is  an im vitro assay of cell-mediated  immunity analogous  to  \n vivo  host versus
graft reactions.
      Mice  (DBA/2J) fed  13, 130,  or  1300 ppm  lead for  10  weeks were evaluated  for  responsive-
ness in mixed lymphocyte cultures.   The 130-ppm lead dose tended to  stimulate the lymphocyte
reaction,  although no change was  observed at the other dose  levels  (Koller  and Roan,  1980b).
In another study  (Lawrence, 1981a),  mice (CBA/J) were fed 16, 80, 400, or 2000 ppm  lead for
four weeks.  The  16 and  80  ppm  doses slightly stimulated, while  the  2000 ppm dose  suppressed,
the  mixed  lymphocyte  reaction.    It  is important to note that in these i_n vitro  MLC  assays,
2-ME was present  in the  culture medium, and the 2-ME may have reversed the jm vivo effects of
 lead, as  was observed  for the  jn vitro PFC responses (Blakley and Archer, 1981).
      The data  on  the  effects  of  lead on humoral and cell-mediated immunity  indicate  that vn
 vivo lead  usually is  immunosuppressive, but  additional studies  are  necessary to fully under-
 stand  the  temporal and  dose  relationship  of lead's immunomodulatory  effects.  The  jn vitro

                                           12-255

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analysis of  immune  cells exposed to lead HI vivo suggest that the major cell type modified is
the  macrophage;  the suppress!ve  effects of  lead  may be  readily reversed  by  thiol  reagents
possibly acting as chelators.
12.8.4.3   Interferon.   Interferons (IF)  are a family of  low-molecular-weight  proteins  which
exhibit antiviral activity in sensitive cells through processes requiring new cellular RNA and
protein synthesis (Stewart, 1979).  it has been speculated that tfie enhanced susceptibility Of
lead'treated mice to  infectious  virus challenge might be due to a decreased capacity of  these
animals  to produce viral  or immune  interferons  or  to  respond  to  them.   Studies by Gainer
(1974,  1977a)  appeared to resolve this  question and indicated that exposure of  CD-I  mice to
lead  does  not  inhibit  the antiviral action  of  viral  IF  iji vivo or jn vitro.  In the later of
the  two  studies,  lead  exposure  inhibited the protective effects  of the IF inducers Newcastle
disease  virus  and poly  I:poly  C against encephalomyocarditis  virus  (EMC)-induced mortality.
These data  suggest  that, although lead did not directly interfere with the antiviral  activity
of interferon, it might suppress viral IF production in vivo.  Recently, Blakley et al.  (1982)
re-examined  this  issue  and  found that  female  BDFj  mice exposed to  lead-acetate in  drinking
water at concentrations  ranging  from 50 to  1000 jjg/ml for three weeks produced amounts  of IF
similar to  controls given a viral IF inducer, Tilorone.   Similarly, the jji vitro induction of
immune  IF   by  the  T-cell  mitogens—phytohemagglutinin,  concanavalin  A,  and  staphylococcal
enterotoxin--in  lymphocytes  from lead-exposed  mice were unaltered  compared  with  controls
(Blakley et  al.,  1982).   Thus,  lead exposure does not appear to significantly alter the lym-
phocyte's ability to produce immune interferon.  Therefore, it must be assumed that increased
viral susceptibility associated with  chronic lead exposure  in  rodents  is  by mechanisms  other
than interference with production of or response to interferon.

12.8.5  Lymphocyte Activation by Mitogens
     Mitogens are lectins that induce activation,  blast-cell transformation, and proliferation
in resting  lymphocytes.   Certain  lectins bind specifically  to  (1)  T-cells (i.e., phytohemag-
glutinin [PHA]  and  concanavalin  A [Con A]),  (2)  B-cells  (i.e.,  lipopolysaccharide  [IPS] of
gram-negative  bacteria),  or (3) both  (i.e.,  pokeweed mitogen  [PWM]).   The  resulting  blasto-
genic response can  be  used to assess changes  in  cell  division of T- and  B-lymphocytes.   The
biological  significance  of  the  following studies  is difficult  to interpret since exposure to
lead  was either jjn vivo or ir\ vitro  at different doses and  for different  exposure  periods.
12.8.5.1   In Vivo Exposure.   Splenic lymphocytes  from  Swiss Webster  mice exposed orally to
2000  ppm  lead  for 30  days  had  significantly depressed proliferative responses  to PHA (Table
12-27) which were not observed after 15  days of  exposure (Gaworski  and Sharma,  1978).   Sup-
pression was  likewise observed with  PWM, a  T- and B-cell  mitogen.  These  observations with

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                                       TABLE 12-27.  EFFECT OF LEAD EXPOSURE ON MITOGEN ACTIVATION OF LYMPHOCYTES
ro
cn
Species
Mice
Mice
Rats
Mice
Mice
Mice
Mice
Lead dose and exposure
In vivo, 250 and 2000
ppm, 30 days
In vivo, 13, 130, and 1300
pp«, 10 weeks
In vivo, pre/postnatal
25 and 50 ppn, 7 weeks
In vivo. 0.08-10 *H, 4 weeks
In vivo, 1300 ppa, 8 weeks
In vivo, 50, 200, and 1000 ppa,
T~weeks
In vitro. 10"*-10"6 M for
Mitogen3
PHA (T-Cell)
PWH (T and B-Cell)
Con A fT-Cell)
LPS (B-Cell)
Con A
PHA
Con A, PHA
LPS
Con A, PHA
LPS
Con A, PHA, SEA
LPS
Con A, PHA
Effect
Significantly depressedhat
2000 ppm on day 30 only
Significantly depressed at
2000 pee on both days 15
and 30°
No effect
No effect
Significantly depressed at
25 and 50 ppn
Significantly depressed at
BO ppn only
No effect
Depressed at 2 and 10 wH
Significantly depressed
No effect
Increased to allc
No effect
Slightly increased at
Reference
Gaworski and
Shanw (1978)
Roller et al. (1979)
Faith et aJ. (1979)
Lawrence (1981c)
Neil an et al. (1980)
Biakley and Archer (1982)
Lawrence (1981a,b)
                Mice        In vitro. 0.1, 0.5, 1.0
                            Tor full culture period
                Mice        In vitro. 10"3-10"7 M
                            Tor 72 hours
LPS

PHA

PWM


LPS
highest dose at day 2, no
effect at day 3.5   .
Increased up to 245JT

Increased at all doses by
up to 453X°
Increased by approximately
250X at 0.1 and 0.5 nM only

Increased by up to 312%
Gaworski and
  Shama (1978)
Shenker et al.  (1977);
  Gallagher et al.
  
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T-cell mitogens were confirmed in Sprague-Daw'ley rats exposed orally to 25 or 50 ppm lead pre-
and  postnatally  for seven weeks (Faith  et  al.,  1979).   Splenic T-cell responses to Con A and
PHA  were  significantly diminished.   A similar depression  of Con A and PHA responses occurred
in  lymphocytes  from C57B1/6 mice exposed to  1300  ppm lead  for 8 weeks (Neilan et al., 1980).
Lead  impaired  blastogenic transformation of  lymphocytes by  both T-cell mitogens, although the
B-cell proliferative response to IPS was not  impaired.
      In contrast  to reports that lead exposure suppressed the blastogenic response of T-cells
to  mitogens,  several  laboratories  have  reported that lead  exposure  does  not suppress T-cell
proliferative  responses  (Koller  et al.,  1979;  Lawrence,  1981c;  Blakley and  Archer,  1982).
These  differences  are  not easily reconciled  since  analysis  of the lead dose employed and ex-
posure  period  (Table 12-26) provides  little  insight into the observed  differences  in T-cell
responses.  In  one case,  a dose of  2000 ppm  for 4 weeks produced a clear depression, while a
lesser dose of 1300 ppm produced no effect at 10 weeks in another laboratory.  These data are
confusing  and  may reflect technical differences in  performing  the T-cell  blastogenesis assay
in  different  laboratories, a  lack of careful  attention to lectin  response  kinetics,  or the
influence  of  suppressor  macrophages.   Thus,  no  firm conclusion  can  be drawn  regarding the
ability of jj] vivo exposure to lead to impair the proliferative capacity of T-cells.
     The blastogenic response of B-cells to LPS was unaffected in four different _ui vivo stud-
ies  at  lead exposure levels of 25-1300  ppm (Roller et al., 1979; Faith  et  al., 1979; Neilan
etal., 1980;  Blakley  and  Archer,  1982).  Lawrence (1981c),  however,  reported that the LPS
response was suppressed after  4 weeks exposure at  2 and 10 mM  lead.   The  weight of the data
suggests that  the  proliferative  response of  B-cells  to  LPS is probably not severely impaired
by lead exposure.
12.8.5.2   In Vitro Exposure.  The  biological  relevance of immunological studies in which lead
was  added  in vitro to  normal rodent splenocytes in the presence of a mitogen (Table 12-27) is
questionable since differences probably reflect either a direct toxic or stimulatory effect by
the  metal.   These  models may,  however, provide useful  information regarding  metabolic and
functional responses in lymphocytes using lead as a probe.
     In one study, lymphocytes were cultured  in the presence of lead (10  , 10   , and 10   M).
A slight but significant  increase in lymphocyte transformation occurred on day 2 at the high-
est  lead  dosage when  stimulated  with Con  A  or  PHA (Lawrence, 1981b).  In a follow-up study
where the  kinetics  of  the lectin response  were  examined (Lawrence,  1981a),  lead (10~ , 10"  ,
and  10"   M)  significantly  suppressed  the  Con  A-  and PHA-induced proliferative responses of
lymphocytes on day  2,  but not on days 3-5.   In yet another jm  vitro exposure study, lympho-
cytes  cultured in  the presence  of 0.1,  0.5,  or  1.0  mM  lead  had  a  significantly enhanced
response to PHA (Gaworski and Sharma, 1978).  It should be kept in mind when considering these

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jn vitro  exposure observations  that  lead has  been demonstrated to be  directly  mitogenic  to
lymphocytes  (Shenker  et al.,  1977).   The data  discussed  here suggest that lead may  also  be
slightly co-mitogenic with T-cell mitogens.  Direct exposure of lymphocytes in culture to lead
can also  result  in  decreased lymphocyte viability (Gallagher et al., 1979).   In vitro studies
on  the effect  of  lead on  the  B-cell  blastogenic  response  to  IPS  indicated that  lead  is
potently  co-mitogenic with  LPS and enhanced the proliferative response of B-cells by 245 per-
cent (Lawrence 1981b,c) to 312 percent (Shenker et al., 1977; Gallagher et al., 1979).

12.8.6    Macrophage Function
     The  monocyte/macrophage  is  involved with phagocytosis, bactericidal activity,  processing
of  complex  antigens for  initiation of  antibody  production,  interferon production, endotoxin
detoxification,  and immunoregulation.   Since some  of these  functions  are altered  in lead-
treated  rodents  (Table 12-28),  the  monocyte/macrophage or comparable  phagocytic cell in the
liver  has been suggested as a possible  cellular target for lead (Trejo et al.} 1972; Cook et
al., 1974; MUller et al., 1977;  Luster et  al., 1978;  Blakley and Archer, 1981).
     Several  laboratories  have shown that a single  i.v. injection of lead impaired the phago-
cytic  ability of the reticuloendothelial  system  (RES)  (Trejo  et al., 1972; Cook et al., 1974;
Filkins  and  Buchanan,  1973).   Trejo et  al.  (1972) found that an  i.v.  injection  of 5 mg lead
impaired  vascular  clearance  of colloidal carbon  that resulted from  an  impaired  phagocytic
ability  of  liver Kupffer cells.    Similarly, others  have confirmed that  lead injected  i.v. de-
pressed  intravascular  clearance  of colloidal carbon (Filkins  and Buchanan, 1973) as well as a
radiolabeled lipid  emulsion (Cook et al.,  1974).   Opposite effects on  RES function have been
seen  when lead  was given  orally  (Keller and Roan,  1977).   Similarly,  Schlick and Friedberg
(1981)  noted that  a 10-day exposure  to 10-1000 pg  lead  enhanced  RES clearance and endotoxin
hypersensitivity.
      Lead has  likewise been  demonstrated to suppress macrophage-dependent  immune responses
(Blakley  and Archer, 1981).   Exposure  of BDFt mice to lead (50  ppm)  for three  weeks in drink-
ing  water suppressed  jm vitro  antibody RFC responses to the macrophage-dependent antigens,
sheep  red blood cells  or  dinitrophenyl-Ficoll,  but not to the macrophage-independent  antigen,
E.  coli  lipopolysaccharide.   The macrophage substitute,  2-mercaptoethanol,   and  macrophages
from  non-exposed mice  restored  lead-suppressed  response.   Castranova et al.  (1980) found that
cultured  rat alveolar  macrophages  exposed to lead had depressed  oxidative  metabolism.
      The  effects of heavy  metals on endotoxin  hypersensitivity were first observed  by  Selye et
al.  (1966),  who described  a  100,000-fold increase  in  bacterial endotoxin  sensitivity in rats
given lead  acetate.   The  increased  sensitivity to  endotoxin was  postulated  to  be  due to a
blockade of the RES.   Filkins (1970)  subsequently  demonstrated that  endotoxin detoxification

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                       TABLE 12-28.  EFFECT OF  LEAD ON MACROPHAGE AND RETICULOENDOTHELIAL SYSTEM FUNCTION
  Species
    Lead dose
    and mode
     Parameter
  Effect
     Reference
  Rat
   Rat
   Mouse
ro
i
   Guinea Pig
   Rat
   Mouse
   Mouse
2.25
single intravenous
injection

5 mg,
single intravenous
injection

13, 130, 1300 ppm
oral, 10-12 weeks
  _3   _6
10  -10  M, in vitro


10" -10" M, in vitro
50-1000 ppm oral,
3 weeks
10-1000 pg,
10 days, intravenous
injection
Vascular clearance;
lipid emulsion
endotoxin sensitivity

Vascular clearance;
colloidal carbon
endotoxin sensitivity

Phagocytosis
Macrophage migration
Macrophage oxygen
metabolism

Plague-forming cell
response to macrophage
dependent antigens

Vascular clearance
Depressed
Increased
Depressed
Increased
Depressed


Depressed


Depressed


Depressed
Enhanced at
10 days;
no effect
at >30 days
Cook et al.  (1974);
  Trejo et al.  (1972)
Trejo et al.  (1972);
  Filkins and
  Buchanan (1973)

Kerkvliet and Baecher-
  Steppan (1982)

Kiremidjian-
  Schumacher et al. (1981)

Castranova et al. (1980)
Blakley and Archer
  (1981)
Schlick and
  Friedberg (1981)
                                           Endotoxin sensitivity
                                                     Increased

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1s primarily a  hepatic  macrophage-mediated event that is profoundly impaired by lead exposure
(Trejo and Di Luzio,  1971;  Filkins and Buchanan, 1973).   The  several  types of data described
above suggest  that macrophage dysfunction  may  be contributing to  impairment  of  immune  func-
tion, endotoxin detoxification, and host resistance following lead exposure.

12.8.7  Mechanisms of Lead Immunomodulation
     The mechanism of toxic action of lead on cells is complex (see Section 12.2).  Since lead
has  a high  affinity for sulfhydryl groups, a likely subcellular alteration accounting for the
immunomodulatory  effects of  lead  on immune  cells  is  its association with  cellular thiols.
Numerous studies  have indicated  that surface and intracellular thiols are involved in lympho-
cyte activation,  growth, and  differentiation.   Furthermore, the study by  Blakley and Archer
(1981) suggests that  lead may inhibit the macrophage's presentation of stimulatory products to
the  lymphocytes.   This  process  may rely  on  cellular thiols since  the  inhibitory effects of
lead can be overcome by an  exogenous  thiol  reagent.   Goyer and Rhyne  (1973) have  indicated
that lead  ions  tend to  accumulate on cell  surfaces, thereby possibly affecting surface recep-
tors and cell-to-cell communication.  A study by  Koller and Brauner (1977)  indicated  that lead
does alter C3b binding to its cell surface  receptor.

12.8.8   Summary
     Lead renders animals  highly susceptible to  endotoxins  and infectious agents.   Host sus-
ceptibility  and the humoral immune system  appear to be particularly sensitive.   As postulated
in recent studies,  the macrophage may be the primary immune  target  cell of  lead.   Lead-induced
immunosuppression occurs at  low  dosages that  induce  no  evident  toxicity and, therefore, may be
detrimental  to  the health of animals and perhaps  of  humans.  The data  accumulated to  date pro-
vide good  evidence that lead  affects  immunity, but  additional  studies are  necessary  to eluci-
date the actual  mechanism  by which  lead  exerts  its  immunosuppressive  action.   Knowledge of
the  effects  of lead  on  the  immune system  of man is  lacking and must be properly ascertained
in  order to  determine  permissible  levels  for human  exposure.   However, since  this  chemical
affects  immunity  in  laboratory animals  and  is  immunosuppressive at very  low  dosages,  its
potential  serious effects in man should  be carefully considered.
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 12.9  EFFECTS OF  LEAD ON OTHER ORGAN SYSTEMS
 12.9.1  The Cardiovascular System
      Lead  has  long been  reported to  be associated with cardiovascular effects, at  least at
 high  exposure  levels.   Some of the older literature bearing on this subject is reviewed here
 In  addition,  because  one of the  the  best  understood pathophysiologic  mechanisms of hyperten-
 sion  in humans  is  that resulting  from renal disease,  some clinical  evidence  linking lead-
 induced  renal  effects  to  hypertension  is  discussed in  Section  12.5.3.5.   (A  more  detailed
 discussion of  lead-hypertension relationships,  focusing on recently completed studies,  can be
 found in an Addendum to this document.)
      In  regard to  some  of the older literature on lead's  cardiovascular  effects,  Dingwall-
 Fordyce and Lane (1963) reported a marked increase in the cerebrovascular mortality  rate amona
 heavily  exposed  lead workers as  compared with  the normal expected rate.   These workers  were
 exposed  to  lead  during the first quarter of this century when working  conditions  were quite
 bad.  There has  been  no similar  increase in the mortality rate reported for men employed In
 recent times.
      Cardiovascular  structural  and  functional  changes  have  been noted  for  both adults  and
 children with  acute lead  poisoning,  but to  date  the  extent  of such studies has  been  limited
 For example, cases  have been described with  regard  to  effects on the  myocardium of children
 always  with clinical  signs of  poisoning.  There  is,  of course, the possibility that the  co-
 existence of  lead  poisoning and myocarditis  is  coincidental;  but in many cases in which  en-
 cephalopathy was  present,  the  electrocardiographic  abnormalities disappeared with  chelatlon
 therapy, suggesting that  lead  may have indeed been  the original  etiological  factor (Freeman
 1965; Myerson and Eisenhauer, 1963;  Silver and Rodriguez-Torres, 1968).   Silver and  Rodriguez-
 Torres (1968)  noted abnormal  electrocardiograms  in 21 of 30 children (70  percent) having symp-
 toms  of  lead toxicity.   After  chelation therapy, the electrocardiograms  remained abnormal  In
 only  four (13  percent)  of  the  patients.  In a review of five fatal  cases of lead poisoning In
young children,  degenerative changes  in heart muscle were reported  to be the proximate cause
 of death (Kline, 1960).   It  is not clear that  such  morphological  changes are a specific  re-
 sponse to lead intoxication.   Kdsmider and Petelenz (1962) examined  38  adults  over 46 years  of
 age with chronic  lead poisoning.  They found that 66  percent  had electrocardiographic changes
a rate that was four times  the  expected rate for that age group.
     Electron  microscopy of  the  myocardium  of  lead-intoxicated rats (Asokan, 1974) and mice
 (Khan et  al.,  1977) has shown  diffuse  degenerative  changes.   The susceptibility of the myo-
cardium to toxic  effects of lead was  supported by i_n  vitro studies in rat mitochondria by Parr
and Harris  (1976).   These investigators  found  that the rate of Ca2    removal  by rat  heart
mitochondria is decreased by 1  nmol  Pb/mg protein.  Kopp  and  coworkers  have  demonstrated  de-
pression of contractility,  isoproterenol  responsiveness, and cardiac protein  phosphorylatlon
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(Kopp et al., 1980a),  as  well  as high-energy phosphate  levels  (Kopp et al.,  1980b)  in  hearts
of lead-fed  rats.   Similarly,  persistent  increased susceptibility  to  norepinephrine-induced
arrhythmias  has  been  observed  in  rats  fed   lead  during  the  first   three  weeks  of  life
(Hejtmancik and Williams,  1977, 1978, 1979a,b;  Williams et al.,  1977a,b).
     The cardiovascular effects  of  lead in conjunction with cadmium have been studied in  rats
following chronic low-level  exposure by Perry and coworkers  (Perry  and Erlanger,  1978; Perry
et al.,  1979;  Kopp  et  al.,  1980a,b).  Perry and Erlanger (1978) exposed female weanling Long-
Evans rats to cadmium,  lead, or cadmium plus lead (as acetate salts) at  concentrations of  0.1,
1.0,  or  5.0  ppm  in  deionized drinking water for up to 18 months.  These authors reported  sta-
tistically significant increases  in systolic blood pressure  for both cadmium and lead in the
range  of 15-20 mm  Hg.    Concomitant exposure  to  both cadmium  and  lead usually  doubled  the
pressor effects of either metal alone.  A subsequent study (Kopp et al., 1980a) using weanling
female  Long-Evans  rats exposed  to  5.0  ppm  cadmium,  lead, or  lead  plus  cadmium  in  deionized
drinking water for  15  or 20 months  showed  similar pressor effects of these two metals, alone
or in  combination,  on  systolic  blood  pressure.   Electrocardiograms performed on these  rats
demonstrated  statistically  significant  prolongation  of the  mean PR interval.   Bundle elec-
trograms  also showed  statistically  significant  prolongations.   Other  parameters of cardiac
function were  not markedly  affected.   Phosphorus-31 nuclear  magnetic resonance (NMR) studies
conducted on perchloric acid extracts of liquid nitrogen-frozen  cardiac tissue from these  ani-
mals disclosed statistically significant reductions in adenosine  triphosphate (ATP) levels and
concomitant  increases  in adenosine  diphosphate  (ADP)  levels.   Cardiac  glycerol 3-phosphoryl-
choline  (GPC)  was also found  to be  significantly reduced  using this technique,  indicating a
general  reduction of tissue  high-energy phosphates by  lead  or cadmium.  Pulse-labeling studies
using  32P  demonstrated decreased incorporation of this  isotope  into  myosin light-chain (LC-2)
in all  lead or cadmium treatment groups relative  to controls.
     The results of this group  of studies  indicate that  prolonged  low-dose  exposure to  lead
(and/or cadmium) reduces tissue concentrations  of  high-energy  phosphates in  rat hearts and
suggest that this  effect may be  responsible  for  decreased myosin  LC-2 phosphorylation and
subsequent  reduced  cardiac  contractility.   Other experiments  by these authors (Kopp et al.,
1980b)  were also  conducted on  isolated perfused  hearts  of weanling  female Long-Evans  rats
exposed to cadmium, lead, or  lead  plus cadmium  in deionized drinking  water  at concentrations
of 50  ppm for 3-15 months.   Incorporation of 32P into  cardiac proteins  was  studied  following
perfusion  on inotropic  perfusate  containing  isoproterenol at  a concentration of 7 x 10  M.
Data from  these  studies  showed a statistically significant reduction in cardiac active  tension
in hearts  from cadmium-  or  lead-treated rats.   Incorporation of 32P was also found  to  be sig-
nficantly  reduced in myosin LC-2  proteins.   The authors  suggested  that the  observed decrease

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 in  LC-2 phosphorylation could be  involved  in  the observed decrease in cardiac active tension
 in  lead- or cadmium-treated rats.
     There are conflicting reports regarding whether lead can cause atherosclerosis in experi-
 mental  animals.   Scroczynski  et  al.  (1967) observed  increased  serum  lipoprotein  and choles-
 terol  levels  and cholesterol  deposits in the aortas of rats and rabbits receiving large doses
 of  lead.   On  the other hand,  Prerovska" (1973), using similar doses of lead given over an even
 longer  period of time, did not produce atherosclerotic lesions in rabbits.
     Makasev and Krivdina (1972) observed a two-phase change in the permeability of blood ves-
 sels (first increased, then decreased permeability) in rats, rabbits, and dogs that received a
 solution of  lead acetate.   A phase change  in  the content of catecholamines in the myocardium
 and  in  the  blood  vessels  was  observed in  subacute  lead  poisoning  in dogs  (Mambeeva  and
 Kobkova, 1969).  This effect appears to be  a  link in the complex mechanism of the cardiovas-
 cular pathology of  lead poisoning.

 12.9.2  The Hepatic System
     The effect  of lead poisoning on  liver function  has not been extensively  studied.   In a
 study of 301  workers  in a lead-smelting and  refining facility,  Cooper et al. (1973) found an
 increase  in  serum glutamic   oxaloacetic  transaminase  (SGOT)  activity  in  11.5  percent  of
 subjects with blood lead  levels below 70 MS/dl, in 20 percent of those with blood lead levels
 of about 70 |jg/dl, and in 50 percent of the workers with blood lead levels of about 100 pg/dl.
 The correlation  (r =  0.18)  between blood lead  levels  and SGOT was statistically significant.
 However, there must also  have been exposure to other metals, e.g., cadmium, since  there was a
 zinc plant  in the  smelter.   In lead workers with moderate effects on the hematopoietic system
 and no  obvious renal signs,  SGOT was not increased compared with controls on repeated examina-
 tions (Hammond et  al.,  1980).   In most studies on lead workers, tests for liver function  are
 not included.
     The liver is  the major  organ for the detoxification of drugs.  In Section 12.3.1.3 it is
 mentioned that exposure to lead may cause altered drug detoxification rates as a result of  in-
 terference  with  the  formation of heme-containing cytochrome  P-450,   which is  part of  the
 hepatic mixed  function oxidase system.   This enzyme  system is  involved in  the hepatic bio-
 transformation of  medicaments,  hormones,  and  many environmental chemicals (Remmer et al.,
 1966).   Whereas  a  decrease  in drug-metabolizing  activity clearly  has  been demonstrated  in
experimental  animals given large  doses  of  lead resulting in acute toxicity, the evidence  for
effects of that  type  in  humans is less consistent.  Alvares  et  al.  (1975)  studied the effect
of lead exposure on drug  metabolism in children.   There  was  no  difference  between two normal
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children and eight  children  with biochemical signs of  lead  toxicity as far as their capacity
to metabolize two test  drugs,  antipyrine and phenylbutazone.    In  two acutely poisoned chil-
dren in whom blood  levels  of lead exceeded 60 ug/dl,  antipyrine half-lives were significantly
longer than  normal, and therapy with EDTA  led to biochemical  remission of  the  disease  and
restoration of deranged  drug metabolism  toward normal.  One  of  the "normal" children in this
study had  a  blood  lead  level of 40 ug/dl,  but normal  ALA-D and EP values.  No data were given
on the  analytical   methods used for  indices  of lead  exposure.   Furthermore, the  age  of  the
children varied  from 1  to  7.5  years, which is  significant because,  as pointed out  by  the
authors, drug detoxification  is age-dependent.
     Meredith et  al.  (1977)  demonstrated  enhanced hepatic metabolism  of antipyrine  in lead-
exposed workers  (PbB: 77-195 ug/dl)  following  chelation  therapy.   The  significance of  this
evidence of restored hepatic  mixed oxidase function is, however, unclear because the pretreat-
ment antipyrine  biologic half-life  and  clearance were  not  significantly  different  in lead-
exposed and  control subjects.   Moreover, there were more  heavy smokers among the lead-exposed
workers than controls.   Smoking  increases the drug-metabolizing capacity and may thus counter-
act  the effects  of lead.    Also,  the effect  of chelation  on  antipyrine metabolism  in  non-
exposed control  subjects was not determined.
     Hepatic drug  metabolism was  studied  by Alvares  et  al.  (1976) in  eight adult patients
showing marked effects  of  chronic lead  intoxication on the erythropoietic system.  The plasma
elimination  rate of antipyrine, which, as noted above, is a  drug primarily metabolized by he-
patic microsomal  enzymes,  was  determined  in eight subjects  prior  to and following chelation
therapy.   In seven  of  eight  subjects, chelation  therapy  shortened the antipyrine half-lives,
but the effect was  minimal.   The authors concluded that chronic lead exposure results in sig-
nificant inhibition of   the  heme biosynthetic pathway without  causing significant changes in
enzymatic  activities associated  with  hepatic cytochrome P-450.
     A confounding  factor in the above three studies may be that treatment with EDTA causes an
increase  in the  glomerular  filtration  rate (GFR) if  it has  been reduced  by  lead (Section
12.5.3.3).  This  may cause  a decrease  in the half-lives of drugs.   There  are,  however, no data
on  the  effect of  chelating  agents on GFR  in children or adults with  moderate signs of lead
toxicity.
     In 11 children with  blood lead  levels between  43  and 52 ug/dl,  Saenger et al.  (1981)
found a decrease  in 24-hour urinary  6-beta-hydroxycortisol  excretion that correlated closely
(r = 0.85,  p <0.001)  with a standardized  EDTA  lead-mobilization  test  (1000 mg EDTA/m2 body
surface area).   This  glucocorticoid  metabolite  is  produced by the  same hepatic microsomal
mixed-function oxidase  system that hydroxylates antipyrine.  The authors suggest  that the de-
pression of  6-beta-hydroxylation  of  cortisol  in the  liver  may  provide a non-invasive method
for assessing body  lead  stores  in children (Saenger et al.,  1981).
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     In a few animal studies, special attention has been paid to morphological effects of lead
on  the  liver.   Ledda-Columbano  et al. (1983)  investigated  hepatic  cell  proliferation in male
Wistar  rats  given  1,4,  or 9, i.v.  injections  of  lead nitrate (5 umol/100 g  body  weight)  at
10-day  intervals.   Although  body  weight  was not significantly reduced and  liver cell  deaths
did  not  increase,  liver weight and DNA activity were both significantly increased.   This work
confirmed earlier  findings by Columbano et  al.  (1983)  that a single dose of lead nitrate (10
(jmo1/100  g)  stimulated hepatic DNA  synthesis  in rats.   Although the authors  noted that cell
proliferation could have been due to an adaptive mechanism, such proliferation could also have
significant  implications  for liver carcinogenesis.   More recently these  findings were  repli-
cated and extended by  Dessi et al.  (1984),  who observed a twofold increase in relative liver
weight in rats 48 hours after an i.v. injection of lead nitrate (10 umol/100 g).   The investi-
gators  also  found  various  indications  of significantly  increased cholesterol synthesis  and
glucose-6-phosphate dehydragenase, both of  which were seen as consistent with the hyperplasia
induced by lead.
     White (1977)  gave  eight beagle  dogs  oral  doses  of lead carbonate,  50-100 mg Pb/kg b.w.
for  3-7 weeks.    Lead  concentrations were  not measured in  blood or tissues.  Morphological
changes were noted in  two dogs  exposed from 5 weeks  of  age to 50 mg/kg.  Changes  in  enzyme
activities were  found   in  most  exposed animals;  for example, some dehydrogenases  showed in-
creased activity after short exposure and  decreased activity after longer exposures, mainly in
animals with weight losses.   The small  number of animals and the absence of data  on lead con-
centrations makes it impossible to use these results for risk evaluations.
     Hoffmann et  al.  (1974)  noted moderate  to marked morphological changes  in baboon  livers
after a single  intravenous injection of large  doses  of lead acetate (25 mg/kg b.w.).   It can
be concluded that  effects  on the liver may be expected to occur only at high exposure levels.
If  effects  on  more sensitive systems, viz., the nervous and hematopoietic systems,  are pre-
vented,  no adverse effects should be  noted in the liver.

12.9.3  The Gastrointestinal System
     Colic is usually a consistent early symptom of lead poisoning,  warning of much  more seri-
ous effects  that  are  likely to occur with continued  or more intense lead exposure.   Although
most commonly seen  in  industrial  exposure cases, colic is also a lead-poisoning symptom pres-
ent in infants  and young children.
     Beritic (1971)  examined 64 men  suffering from abdominal colic due  to  lead  intoxication
through occupational exposure.   The  diagnosis  of lead  colic was based on the occurrence  of
severe attacks  of spasmodic abdominal pain accompanied by constipation,  abnormally high  copro-
porphyrinuria,  excessive basophilic stippling, reticulocytosis,  and some degree of anemia (all

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clinical  signs  of  lead  poisoning).   Thirteen  of the  64 patients had  blood lead  levels  of
40-80 ug/dl upon admission.   However,  the report did not indicate how recently the patients'
exposures had been terminated or provide other details of their exposure histories.
     A more recent  report by Dahlgren (1978) focused on the gastrointestinal symptoms of lead
smelter workers whose blood lead levels were determined within two weeks of the termination of
their work exposure.   Of 34  workers with known lead exposure, 27 (79 percent)  complained of
abdominal  pain,  abnormal bowel movements,  and  nausea.   Fifteen of the  27  had abdominal  pain
for more  than  3 months after  removal  from  the  exposure to lead.   The mean (± SD) blood lead
concentration  for  this  group of 15 was  70 (± 4) ug/dl.  There was,  however, no correlation
between  severity  of  symptoms and blood  lead levels, as  those experiencing stomach pain for
less than  3 months  averaged  68  (± 9)  ug/dl and the remaining 7 workers, reporting no pain at
all, averaged 76 (± 9) ug/dl.
     Haenninen et al. (1979)  assessed the incidence of gastrointestinal symptoms in 45 workers
whose blood lead  levels  had  been regularly monitored throughout their exposure and had never
exceded  69 ug/dl-   A significant association between gastrointestinal symptoms (particularly
epigastric pain) and blood lead level was  reported.   This association was more pronounced in
subjects whose  maximal  blood lead levels had reached 50-69 ug/dl,  but was  also noted in those
whose blood lead levels were  below 50 ug/dl.
     Other occupational  studies have also  suggested  a  relationship between lead exposure and
gastrointestinal symptoms (Lilis et al., 1977;  Irwig et  al.,  1978a,b;  Fischbein et al., 1979,
1980).   For  demonstrating  such a relationship, however,  the  most useful  measure of internal
exposure has not necessarily  been blood lead  concentrations.   Fischbein  et  al. (1980) surveyed
a  cross-section of  New York  City telephone cable splicers exposed to lead in the process of
soldering  cables.    Of  the  90 workers evaluated,  19 (21  percent) reported  gastrointestinal
symptoms  related to lead  colic.   The  difference  between mean  blood lead  levels  in those
reporting  GI  symptoms and those  not reporting  such  symptoms  (30 versus  27  ug/dl) was not sta-
tistically significant.   However, mean zinc protoporphyrin concentrations  (67  versus 52 ug/dl)
were significantly  different  (p <0.02)
     Limited  experimental work has been  devoted to  gastrointestinal  function  either in humans
(Lerza  and Fierro,  1958;  Mungo and  Sessa, 1960)  or animals  (Mambeeva,  1963; Cory-Slechta
etal.,  1980).   A  recent study  of  chronically  lead-exposed  rats by  Walsh and Ryden (1984)
indicated  that  concentrations of lead  sufficient to  cause renal and hematological toxicity  did
not appreciably affect gastrointestinal transit.
     Although  gastrointestinal symptoms of  lead exposure are clinically evident in frank lead
intoxication  and may even  be present when blood  lead  levels approach the  30-80 ug/dl  range,
there  is currently insufficient  information  to establish a clear  dose-effect relationship for
the general population at ambient exposure  levels.
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12.9.4  The Endocrine System
     Some evidence exists  for other effects of lead on the endocrine system,  at  least  at  high
levels  of  lead exposure.   Lead is  thought,  for  example,  to decrease thyroid function In  man
and  experimental  animals.   Porritt  (1931)  suggested that  lead dissolved from lead pipes  by
soft water was the cause of hypothyroidism in individuals living in southwest  England.  Later
Kremer  and  Frank (1955)  reported  the  simultaneous  occurrence  of myxedema and plumbism  in a
house painter.  Monaenkova (1957) observed impaired concentration of 131I  by thyroid  glands in
10 of 41 patients with industrial plumbism.   Subsequently,  Zel'tser (1962) showed  that  HI  vivo
131I uptake and  thyroxine  synthesis by rat thyroid were decreased by lead when doses of 2  and
5 percent lead acetate  solution were administered.  Robins et  al.  (1983) reported a clinical
study of 12 workers  with  blood lead levels of 44 (jg/dl  or above.   Seven of the workers showed
low serum thyroxine and estimated free thyroxine levels.   In the same report,  the  authors  also
presented results of a  cross-sectional  study of 47 workers in  which both of  these indices of
thyroid  function  were negatively  related  to blood  lead levels.   The effects were more  pro-
nounced in black men than in white men.   Refowitz (1984) reported that he  was  unable  to corro-
borate the findings of Robins et al. (1983).   However,  his  regression plots of similar  thyroid
function indices consistently showed negative relationships with blood lead levels in 58 work-
ers.  Although these results  did  not  achieve  statistical  significance  in Refowitz1s (1984)
analysis, they suggested  a  stronger negative relationship between thyroxine and blood  lead
levels in white workers than did the data of Robins et  al.  (1983).
     Uptake of  131I,  sometimes  decreased in men with lead  poisoning,  can be  offset  by treat-
ment with thyroid-stimulating  hormone  (TSH)  (Sandstead  et al., 1969;  Sandstead,  1967).   Lead
may act  to depress  thyroid function by  inhibiting thiol groups or by displacing iodine in a
protein sulfonyl iodine carrier (Sandstead,  1967),  and  the  results suggest that excessive  lead
may act  at both the  pituitary and  the  thyroid  gland  itself to  impair thyroid function.   None
of these effects  on  the thyroid system, however, have  been demonstrated to occur  in  humans  at
blood lead levels below 30-40 pg/dl.
     Sandstead et al.  (1970a)  studied the effects  of lead  intoxication on pituitary  and adre-
nal  function  in man and found  that it  may produce clinically  significant hypopituitarism  in
some. The effects of lead  on adrenal function were  less consistent, but  some of  the patients
showed a decreased responsiveness to an inhibitor (metapyrone)  of 11-beta-hydroxylation in  the
synthesis of  cortisol.  This  suggests a possible  impact of  lead  on pituitary-adrenal  hormone
functions.   That  excessive oral  ingestion  of lead may  in  fact  result in  pathological  changes
in the pituitary-adrenal axis is also supported by  other reports (Murashov, 1966;  Pines, 1965)
of  lead-induced  decreased  metapyrone  responsiveness,   a   depressed pituitary  reserve,   and
decreased immunoreactive  adrenocorticotrophic  hormone  (ACTH).    These same  events  may  also

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affect  adrenal  gland  function  inasmuch  as  decreased  urinary  excretion  of  17-hydroxy-
corticosteroids was observed in these patients.   Furthermore, suppression of responsiveness  to
exogenous  ACTH in  the zona  fasciculate  of  the  adrenal  cortex has  been reported  in  lead-
poisoned subjects  (Makotchenko,  1965),  and impairment of the  zona  glomerulosa of the adrenal
cortex has also  been  suggested (Sandstead et al., 1970b).   Once again, however, none of these
effects on adrenal  hormone   function have been shown  to occur at blood lead levels as low as
30-40 ug/dl,
     Other studies  provide  evidence  suggestive  of lead  exposure  effects on endocrine systems
controlling reproductive functions (see also Section 12.6).   For example, evidence of abnormal
luteinizing  hormone  (LH)   secretory  dynamics was  found  in  secondary  lead  smelter  workers
(Braunstein  et al.,  1978).   Reduced  basal  serum testosterone  levels  with normal  basal  LH
levels,  but  a  diminished  rise  in  LH  following  stimulation,  indicated  suppression  of
hypothalamic-pituitary  function.  Testicular biopsies  in   two  lead-poisoned  workmen  showed
peritubular fibrosis  suggesting direct toxic effects of lead  in the testes as well as effects
at  the hypothalamic-pituitary  level.    Lancranjan et al.  (1975) also  reported lead-related
interference with  male reproductive  functions.   Moderately  increased lead absorption (blood
lead  mean  = 52.8  ug/dl)  among a group  of  150  workmen who  had long-term  exposure  to lead in
varying  degrees  was  said  to result  in  gonadal  impairment.   The effects  on the testes were
believed to  be direct, however, in that tests for hypothalamic-pituitary  influence were nega-
tive.
      In regard to  effects of lead on ovarian  function  in human females,  Panova  (1972) reported
a study of 140 women working in a printing plant  for 1-2 months, where ambient air lead levels
were  <7  ug/m3.   Using a classification  of various age groups  (20-25,  26-35, and 36-40 yr) and
type  of ovarian cycle  (normal,  anovular, and  disturbed lutein  phase),  Panova claimed that sta-
tistically significant differences  existed between the  lead-exposed and control groups in the
age  range 20-25 years.  It  should be noted that the report does not show the  age distribution,
the  level  of significance,  or  the data  on specificity of the method  used for  classification.
Also,  Zielhuis and Wibowo  (1976), in  a  critical  review  of the above study, concluded that the
design of  the  study and presentation  of data were such that  it was difficult  to evaluate the
author's  conclusion that chronic exposure to low air lead  levels  leads to disturbed ovarian
function.  Moreover,  no consideration was given  to the  dust levels of lead,  an important fac-
tor  in print shops.   Unfortunately,  little else besides  the  above report exists  in  the  litera-
ture  in  regard to  assessing lead effects  on  human ovarian function or other  factors  affecting
human female  fertility.  Studies  offering firm  data on  maternal  variables such  as  hormonal
state,  which  is  known to  affect the  ability of the  pregnant woman  to carry  the  fetus  full-
term,  are also  lacking,  although certain studies do at  least indicate  that  high-level  lead
exposure  induces stillbirths and abortions  (see Section  12.6).
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     An animal study  by  Petrusz et al.  (1979) reports that orally administered  lead can exert
effects on pituitary  and  serum gonadotropins, which may represent one mechanism by which  lead
affects reproductive functions.  The blood lead levels at which  alterations  in serum and pitu-
itary follicle stimulating  hormone  were observed in neonatal rats, however, were well in ex-
cess of 100 ug/dl.   (Evidence  relating  endocrine function to various recently  reported lead-
associated effects  on  human  fetal  and  child  development,  including effects  on  growth  and
stature, is reviewed in an Addendum to  this document.)
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12.10  CHAPTER SUMMARY
12.10.1  Introduction
     Lead has diverse  biological  effects in humans and  animals.   Its  effects are seen at the
subcellular level  of organellar structures and processes  as  well  as at the  overall  level  of
general  functioning  that  encompasses  all  systems of  the body  operating in a  coordinated,
interdependent fashion.   The present  chapter  not only categorizes  and  describes  the various
biological effects  of lead  but also  attempts  to identify the exposure levels at which  such
effects  occur and the  mechanisms underlying  them.   The  dose-response  curve for  the  entire
range of  biological  effects  exerted by lead is rather broad,  with certain biochemical changes
occurring at relatively low levels of exposure and perturbations in other systems, such as the
liver,  becoming  detectable  only  at relatively  high  exposure  levels.   In terms  of  relative
vulnerability to deleterious  effects of lead, the developing organism generally appears to be
more  sensitive  than the  mature individual.  Additional,  quantitative  examination of overall
exposure-effect  relationships  for lead  is  presented  in Chapter 13.  It should be noted  that
lead has no known beneficial  biological effects.  Available evidence does not demonstrate that
lead is an essential element.

12.10.2  Subcellular Effects of Lead
     The  biological  basis of lead toxicity is  its  ability to bind to ligating groups in bio-
molecular  substances  crucial  to  various  physiological  functions, thereby  interfering  with
these  functions  by,  for  example, competing  with native  essential  metals for binding sites,
inhibiting  enzyme activity,  and  inhibiting  or  otherwise altering essential  ion transport.
These effects are modulated by  the following:  1) the inherent stability of such binding sites
for lead; 2) the compartmentalization  kinetics governing lead distribution among body compart-
ments,  among  tissues, and within cells;  and 3) the  differences  in biochemical  organization
across  cells  and tissues due to  their specific functions.  Given  the complexities introduced
by  items 2 and  3,  it. is not  surprising  that no single  unifying mechanism  of lead toxicity
across  all tissues in  humans and  experimental animals has  yet been  demonstrated.
      Insofar  as  effects  of  lead  on activity of various  enzymes  are  concerned,  many of the
available studies concern ijn vitro behavior of  relatively  pure enzymes with marginal  relevance
to  various  effects rn vivo.   On  the other hand, certain  enzymes  are  basic to the effects of
lead  at the  organ or  organ  system level,  and discussion  is  best  reserved for such effects in
the summary sections  below dealing with  lead's  effects  on  particular organ systems.   This  sec-
tion  is mainly concerned with  organellar  effects of  lead, especially those which  provide  some
rationale  for lead toxicity at higher levels  of  biological organization.   Particular emphasis
is  placed on  the mitochondrion,  because this  organelle is not  only affected  by lead  in numer-
ous  ways but  has  also provided  the  most  data  bearing  on the subcellular  effects  of  lead.
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     The  critical  target organelle  for lead  toxicity  in  a variety of cell and tissue  types
clearly is  the  mitochondrion,  followed probably by cellular and intracellular  membranes.   The
mitochondrial effects take the form of structural changes and marked disturbances in  mitochon-
drial  function  within the cell,  particularly  in energy metabolism and ion  transport.   These
effects in turn are associated with demonstrable accumulation of lead in mitochondria,  both 1n
vivo  and  jni vitro.   Structural  changes include  mitochondrial  swelling in a variety  of  ceTT
types  as  well  as  distortion  and  loss of  cristae,  which occur  at relatively moderate  lead
levels.   Similar changes  have also been  documented in lead  workers across a  range of  ex-
posures.
     Uncoupled  energy metabolism,  inhibited  cellular  respiration using  both succinate  and
nicotinamide adenine dinucleotide (NAD)-linked substrates,  and altered kinetics  of  intracellu-
lar calcium have been demonstrated ni vivo using mitochondria of brain and non-neural  tissues
In some cases,  the  lead exposure level associated with such changes has  been  relatively low.
Several studies  document  the relatively greater sensitivity of this organelle  in young versus
adult animals in terms of mitochondrial respiration.   The cerebellum appears  to  be  particular-
ly sensitive, providing a connection between mitochondrial  impairment and  lead  encephalopathy.
Lead's impairment of mitochondrial function in the developing brain has also  been consistently
associated with  delayed  brain  development,  as indexed  by  content  of  various cytochromes.   jn
the  rat  pup, ongoing  lead  exposure from birth  is required for this effect to be expressed,
indicating that  such  exposure  must  occur before, and is inhibitory to, the burst of  oxidative
metabolism activity that occurs in the young rat at 10-21 days postnatally.
     In vivo lead exposure of adult rats also markedly inhibits calcium turnover in a  cellular
compartment of the cerebral  cortex that appears to be the mitochondrion.   This effect  has  been
seen at a brain lead level  of 0.4 M9/9-   These  results are consistent with a  separate  study
showing increased retention  of calcium in the brains of lead-dosed guinea pigs.  Numerous  re-
ports  have  described  the HI  V1V°   accumulation  of  lead  in  mitochondria  of  kidney, liver
spleen, and  brain  tissue,  with one  study showing  that  such uptake  was  slightly more  than
occurred  in  the  cell  nucleus.   These data are not only consistent with deleterious effects  of
lead on mitochondria but are  also   supported  by other investigations w vitro.  Significant
decreases  in mitochondrial respiration jn vitro using both  NAD-1inked  and  succinate substrates
have been observed  for brain  and non-neural  tissue  mitochondria  in  the  presence  of  lead  at
micromolar levels.   There appears to be substrate specificity in the inhibition of  respiration
across  different tissues, which may  be  a  factor  in differential organ  toxicity.   Also,  a
number of enzymes involved  in  intermediary metabolism in  isolated  mitochondria have  been  ob-
served to  undergo significant inhibition of activity  with lead.
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     Of particular interest  regarding  lead's effects on  isolated mitochondria  are  ion trans-
port effects,  especially in  regard  to calcium.   Lead movement  into  brain and  other tissue
mitochondria  involves  active  transport,  as  does  calcium.   Recent  sophisticated  kinetic
analyses  of desaturation  curves for  radiolabeled  lead  or  calcium indicate  that there  is
striking  overlap in  the cellular  metabolism of  calcium and lead.   These studies not  only
establish the basis for the easy entry of lead into cells and cell compartments, but also pro-
vide a basis for lead's impairment of intracellular ion transport, particularly in neural  cell
mitochondria, where  the capacity for calcium transport is 20-fold higher  than  even  in heart
mitochondria.
     Lead is  also  selectively taken up in isolated mitochondria ui vitro, including the mito-
chondria  of  synaptosomes  and brain capillaries.  Given the  diverse and extensive evidence of
lead's  impairment of  mitochondria!  structure and function as viewed from a subcellular level,
it is not surprising that these derangements  are logically held to be the basis of dysfunction
of heme biosynthesis,  erythropoiesis,  and the central nervous system.  Several key enzymes in
the  heme  biosynthetic  pathway are intramitochondrial, particularly ferrochelatase.   Hence, it
is to  be expected  that entry of lead into mitochondria will impair overall heme biosynthesis,
and  in fact  this  appears to  be the case  in the  developing  cerebellum.   Furthermore, rela-
tively  moderate  levels of lead may be  associated with its entry into mitochondria and conse-
quent expressions of mitochondrial injury.
     Lead exposure provokes  a typical cellular  reaction  in  humans  and other species that has
been morphologically  characterized as a  lead-containing  nuclear  inclusion body.  While it has
been  postulated  that  such  inclusions  constitute  a cellular protection  mechanism,   such  a
mechanism is  an  imperfect one.  Other  organelles,  e.g.,  the mitochondrion, also take up lead
and  sustain  injury in  the presence of nuclear inclusion formations.
     In theory,  the  cell  membrane is  the first  organelle  to encounter  lead and it  is not
surprising  that cellular effects  of lead  can be  ascribed  to  interactions  at cellular and
intracellular membranes  in  the  form of  disturbed  ion  transport.   The inhibition of membrane
(Na+,K+)-ATPase  of erythrocytes  as  a  factor in  lead-impaired erythropoiesis  is noted else-
where.   Lead also  appears to  interfere  with the normal  processes  of calcium transport across
membranes of different  tissues.   In peripheral  cholinergic synaptosomes,  lead is associated
with retarded release  of  acetylcholine  owing to a blockade of  calcium binding  to the membrane,
while   calcium accumulation  within nerve endings can  be ascribed to  inhibition of  membrane
(Na+,K+)-ATPase.
     Lysosomes  accumulate in renal proximal  convoluted tubule cells  of rats and rabbits  given
lead over a  range of  dosing.   This also appears  to occur in the  kidneys  of  lead  workers and
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seems to  represent  a  disturbance in normal lysosomal function, with the accumulation of lyso-
somes being due  to  enhanced degradation of proteins  because  of the effects of lead elsewhere
within the cell.

12.10.3.   Effects of Lead on Heme Biosynthesis, Erythropoiesis, and Erythrocyte Physiology in
          Humans and Animals'
     The  effects of  lead  on heme biosynthesis are well  known because of their clinical  promi-
nence and the  numerous  studies of such effects  in  humans  and experimental  animals.   The pro-
cess of heme biosynthesis starts with glycine and succinyl-coenzyme A, proceeds through  forma-
tion of  protoporphyrin  IX,  and culminates with  the  insertion of divalent iron into  the por-
phyrin ring  to form  heme.   In addition  to  being a constituent of  hemoglobin,  heme  is  the
prosthetic group of many tissue hemoproteins  having variable functions, such as myoglobin,  the
P-450 component of  the  mixed-function oxygenase system, and the cytochromes of cellular ener-
getics.    Hence,  disturbance of  heme  biosynthesis by  lead poses the  potential for multiple-
organ toxicity.
     In  investigations  of lead's effects  on  the  heme  synthesis pathway, most attention  has
been  devoted   to the  following:  (1) stimulation  of mitochondrial  delta-aminolevulinic  acid
synthetase (ALA-S),  which mediates  formation of delta-aminolevulinic  acid  (ALA);  (2)  direct
inhibition of  the cytosolic  enzyme,  delta-aminolevulinic acid  dehydrase  (ALA-D), which cata-
lyzes formation of  porphobilinogen  from two  units of ALA;  and (3) inhibition of  insertion of
iron (II) into protoporphyrin IX to form heme, a process mediated by ferrochelatase.
     Increased ALA-S activity  has  been  found  in  lead workers as well as in lead-exposed ani-
mals, although an actual decrease in enzyme activity has also been observed in several experi-
mental studies using  different exposure methods.  It appears,  then,  that the effect on ALA-s
activity may depend  on  the  nature of the  exposure.   Using rat liver  cells  in  culture,  ALA-S
activity was stimulated jji vitro at lead levels as low as 5.0 uM or 1.0 ug/g preparation.   The
increased activity was due to biosynthesis of more enzyme.   The blood lead threshold for stim-
ulation  of  ALA-S activity  in  humans,  based  on a study  using  leukocytes  from lead workers,
appears  to  be  about 40  pg/dl.  Whether  this  apparent threshold  applies to other tissues
depends on how well  the sensitivity of leukocyte mitochondria mirrors that in other systems.
The  relative impact  of  ALA-S activity  stimulation on ALA  accumulation at lower lead exposure
levels appears to be  much less than the effect of  ALA-D activity inhibition.  ALA-D activity
is  significantly  depressed  at  40  ug/dl blood lead, the  point at which ALA-S activity only
begins to be affected.
     Erythrocyte ALA-D  activity is  very sensitive to inhibition  by lead.   This inhibition is
reversed  by reactivation  of  the sulfhydryl group with agents such as dithiothreitol, zinc, or
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zinc and glutathione.  Zinc  levels  that achieve reactivation,  however,  are  well  above  physio-
logical levels.   Although  zinc appears to offset  the  inhibitory effects of lead observed  in
animal  studies and  in  human  erythrocytes rn  vitro, lead workers exposed to  both  zinc and  lead
do not show  significant  changes  in  the relationship of ALA-D activity to blood lead when  com-
pared with workers  exposed just  to  lead.  Nor  does  the range  of physiological zinc levels  in
nonexposed subjects affect ALA-D  activity.   In contrast, zinc  deficiency in  animals signifi-
cantly inhibits ALA-D  activity,  with  concomitant accumulation  of ALA  in urine.   Because  zinc
deficiency has also  been demonstrated to increase lead absorption,  the possibility  exists for
the following dual effects  of such deficiency on ALA-D activity:  (1) a direct effect on acti-
vity due  to reduced zinc availability;  and  (2) increased lead  absorption  leading  to  further
inhibition of activity.
     Erythrocyte  ALA-D  activity  appears  to  be  inhibited  at virtually  all blood lead levels
measured so  far,  and any threshold  for this  effect in either adults or children remains to be
determined.  A further measure of this enzyme's sensitivity to lead is a report that  rat  bone
marrow suspensions  show  inhibition  of ALA-D  activity  by  lead  at a level of 0.1 ug/g  suspen-
sion.  Inhibition of ALA-D  activity  in erythrocytes apparently reflects a similar effect  in
other  tissues.  Hepatic  ALA-D  activity in lead workers was inversely correlated with erythro-
cyte activity  as  well as  blood  lead levels.   Of  significance are experimental animal  data
showing that (1) brain ALA-D activity is inhibited with lead exposure, and (2) this  inhibition
appears to  occur  to a greater extent in developing animals than in adults,  presumably  reflec-
ting greater retention of lead  in  developing  animals.  In the avian  brain,  cerebellar ALA-D
activity is  affected to  a  greater extent than that of the cerebrum and, relative to lead  con-
centration,  shows inhibition approaching that occurring in erythrocytes.
     Inhibition of  ALA-D activity by lead  is  reflected by elevated  levels of its  substrate,
ALA, in blood,  urine,  and  soft tissues.  Urinary ALA is employed extensively as an indicator
of excessive lead exposure in  lead workers.   The diagnostic value of this measurement in pedi-
atric  screening,  however,  is limited when only  spot urine collection is done; more satisfac-
tory  data  are  obtainable  with  24-hr  collections.   Numerous   independent studies  document a
direct correlation  between  blood  lead and  the logarithm of urinary ALA in  human  adults and
children;  the  blood  lead  threshold  for  increases in urinary  ALA  is  commonly accepted as 40
ug/dl.  However,  several studies of lead workers  indicate that  the correlation between urinary
ALA  and  blood lead continues below  this value;  one study found that  the  slope of the dose-
effect curve in lead workers depends  on  the  level  of exposure.
     The health significance of  lead-inhibited  ALA-D activity and accumulation of ALA  at  lower
lead exposure  levels is controversial.   The "reserve  capacity" of ALA-D activity is such that
only  the  level of  inhibition associated with  marked  accumulation  of the enzyme's substrate,

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ALA, in accessible  indicator  media may be significant.   However,  it  is not possible  to  quan-
tify at lower  levels  of lead exposure the relationship of urinary ALA to target  tissue levels
or to  relate the  potential  neurotoxicity of ALA  at  any accumulation  level  to levels  in  indi-
cator  media.   Thus,  the blood lead threshold  for neurotoxicity of ALA may be different  from
that associated with increased urinary excretion of ALA.
     Accumulation of  protoporphyrin  in erythrocytes of lead-intoxicated  individuals  has  been
recognized  since  the 1930s, but  it  has  only recently been possible  to  quantitatively assess
the nature of this effect via development of sensitive, specific microanalysis methods.   Accu-
mulation of protoporphyrin  IX  in erythrocytes results from impaired placement of iron (II)  in
the porphyrin  moiety  in heme  formation,  an intramitochondrial  process mediated by ferrochela-
tase.   In  lead exposure,  the  porphyrin acquires a zinc ion in  lieu of native iron,  thus  form-
ing zinc protoporphyrin  (2PP), which is  tightly  bound  in available heme pockets for  the life
of the erythrocytes.  This  tight sequestration contrasts  with  the relatively mobile nonmetal,
or free, erythrocyte protoporphyrin (FEP) accumulated in the congenital  disorder  erythropoiet-
ic protoporphyria.
     Elevation  of erythrocyte ZPP has been extensively documented as  exponentially correlated
with blood lead in children and adult lead workers and is  currently considered one of  the best
indicators  of  undue lead exposure.   Accumulation of  ZPP only occurs  in erythrocytes formed
during lead's  presence  in  erythroid  tissue;  this results  in a lag of at least  several  weeks
before its  buildup  can  be measured.   The  level  of  ZPP accumulation  in  erythrocytes  of  newly
employed lead  workers continues  to increase after  blood  lead  has  already  reached  a  plateau.
This influences the  relative  correlation of ZPP and blood lead in workers with short  exposure
histories.   Also,  the ZPP level  in blood  declines much more slowly than blood lead,  even  after
removal from exposure or after  a drop in  blood  lead.   Hence,  ZPP  level  appears  to be a more
reliable indicator of continuing intoxication from lead resorbed from  bone.
     The threshold for  detection of  lead-induced ZPP accumulation is  affected by the  relative
spread of  blood lead and corresponding ZPP  values  measured.   In young children   (<4  yr  old),
the ZPP elevation associated  with iron-deficiency anemia  must  also be considered.   In adults,
numerous studies  indicate  that  the  blood lead  threshold for  ZPP  elevation is   about 25-30
ug/dl.   In children 10-15 years  old,  the  threshold is about 16  ug/dl;  for this age group,  iron
deficiency  is  not a  factor.   In one  study,  children  over 4 years old showed the same thresh-
old, 15.5  ug/dl,  as  a second group under 4 years old, indicating that iron  deficiency was not
a factor in the study.   At 25 ug/dl   blood lead,  50  percent of the children had  significantly
elevated FEP levels (2 standard deviations above the reference  mean FEP).
     At blood  lead  levels  below  30-40 ug/dl, any assessment of the EP-blood lead relationship
is strongly influenced  by the relative  analytical  proficiency of  measurements  of  both  blood
lead and EP.  The types  of statistical analyses used are also important.   In a recent  detailed
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statistical  study involving 2004  children,  1852 of whom had blood lead values  below 30  ug/dl,
segmental  line and probit  analysis  techniques were employed to  assess  the dose-effect  thres-
hold and  dose-response  relationship.   An  average blood  lead  threshold for the  effect using
both statistical  techniques  was  16.5  ug/dl  for  the  full  group  and for  those  subjects  with
blood lead below 30 ug/dl.   The effect of iron deficiency was tested for and removed.  Of par-
ticular interest was the finding that blood lead values of 28.6 and 35.7 ug/dl  corresponded to
EP elevations more than  1  or 2 standard deviations, respectively, above the reference mean in
50 percent of the children.   Hence, fully  half  of the children had significant elevations of
EP at  blood  lead  levels  around  30 |jg/dl.   From various reports,  children  and  adult females
appear  to  be more  sensitive  to  lead's  effects on EP accumulation at  any given  blood  lead
level; children are somewhat more sensitive than adult females.
     Lead's effects on heme formation are not restricted to the erythropoietic system.  Recent
studies show that the reduction of serum 1,25-dihydroxyvitamin D seen with even low-level lead
exposure  is   apparently  the  result  of  lead-induced  inhibition  of  the  activity  of renal
1-hydroxylase,  a cytochrome  P-450 mediated  enzyme.    Reduction  in  activity of  the hepatic
enzyme  tryptophan pyrrolase and  concomitant  increases in plasma  tryptophan as  well  as brain
tryptophan,  serotonin,  and  hydroxyindoleacetic acid  have been  shown  to be  associated with
lead-induced reduction of the hepatic heme pool.  The heme-containing protein cytochrome P-450
(an  integral  part of the  hepatic mixed-function oxygenase system)  is  affected  in humans and
animals by  lead  exposure,  especially acute  intoxication.   Reduced P-450  content correlates
with  impaired activity  of  detoxifying enzyme systems such as  aniline hydroxylase and aminopy-
rine demethylase.  It is also responsible for reduced 6p-hydroxylation of cortisol in children
having moderate  lead exposure.
     Studies of  organotypic chick and mouse dorsal  root ganglion  in culture show that the ner-
vous  system  has  heme biosynthetic capability and  that not only  is such capability reduced in
the  presence of  lead  but  production  of porphyrinic material  is increased.   In the neonatal
rat,  chronic lead  exposure resulting  in  moderately  elevated blood lead  is  associated with
retarded  increases in the hemoprotein cytochrome C and  with  disturbed electron transport in
the  developing cerebral cortex.   These data parallel effects of  lead on ALA-D  activity  and ALA
accumulation  in  neural tissue.   When both of these  effects  are viewed in the  toxicokinetic
context  of increased retention of  lead  in both developing  animals  and children, there is an
obvious and  serious potential  for impaired  heme-based  metabolic  function  in  the  nervous system
of lead-exposed  children.
     As  can  be concluded  from  the  above discussion,  the  health  significance  of ZPP  accumula-
tion rests with  the  fact  that it is evidence  of  impaired heme and hemoprotein  formation  in
many tissues  that arises from  entry of  lead into mitochondria.  Such evidence  for reduced heme

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synthesis is consistent with a great deal of data documenting lead-associated effects  on mito-
chondria.   The  relative value  of the  lead-ZPP  relationship in  erythropoietic  tissue as  an
index of this effect in other tissues hinges on the relative sensitivity of the erythropoietic
system  compared  with  other organ systems.  One  study  of rats exposed over  their  lifetime  to
low  levels  of  lead demonstrated that protoporphyrin accumulation  in  renal  tissue  was already
significant at levels  of  lead exposure which produced  little change  in erythrocyte porphyrin
levels.
     Other  steps  in the  heme biosynthesis pathway are  also  known to  be affected by lead,  al-
though  these have  not  been as well  studied on a biochemical  or  molecular level.  Coproporphy-
rin levels are increased in urine, reflecting active lead intoxication.   Lead also  affects  the
activity of the enzyme uroporphyrinogen-I-synthetase in experimental animal  systems, resulting
in an accumulation of its substrate, porphobilinogen.   The erythrocyte enzyme has been report-
ed to be much  more sensitive to lead than the hepatic species,  presumably accounting  for much
of the  accumulated  substrate.   Unlike the case with experimental  animals, lead-exposed humans
show no rise in  urinary  porphobilinogen, which  is  a  differentiating characteristic  of lead
intoxication versus the  hepatic porphyrias.   Ferrochelatase  is an intramitochondrial  enzyme
and impairment of its activity, either directly by lead or via impairment of iron transport to
the enzyme, is evidence of the presence of lead in mitochondria.
     Anemia  is a manifestation  of  chronic lead  intoxication and is characterized as  mildly
hypochromic and usually normocytic.   It is associated with reticulocytosis,  owing to shortened
cell  survival, and the variable presence  of  basophilic stippling.   Its occurrence is  due  to
both decreased production  and increased rate of destruction  of erythrocytes.   In  young chil-
dren (<4 yr old), iron deficiency anemia is exacerbated by lead  uptake,  and vice  versa.   Hemo-
globin  production  is  negatively  correlated  with blood lead in young children, in whom iron
deficiency may be  a  confounding factor, as well  as in lead workers.   In one study, blood lead
values that were  usually below 80 ug/dl  were inversely correlated  with hemoglobin content.   In
these subjects no  iron  deficiency was found.   The blood lead threshold for reduced hemoglobin
content is about  50 ug/dl  in adults and somewhat lower (~40 pg/dl) in  children.
     The mechanism of lead-associated anemia appears to be a combination of reduced hemoglobin
production  and shortened  erythrocyte survival due  to direct cell injury.   Lead's  effects  on
hemoglobin production involve  disturbances of both heme and globin biosynthesis.   The hemoly-
tic component to  lead-induced anemia appears to be caused by increased cell fragility and  in-
creased osmotic  resistance.   In one study using rats,  the hemolysis associated with vitamin E
deficiency, via  reduced cell  deformability,  was exacerbated  by lead  exposure.   The molecular
basis for increased cell  destruction rests with inhibition of (Na+,  K+)-ATPase and  pyrimidine-
S'-nucleotidase.   Inhibition  of  the  former enzyme leads to cell  "shrinkage" and  inhibition of

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the  latter  results in  impaired  pyrimidine nucleotide  phosphorolysis  and disturbance  of  the
activity of the purine nuclcotides necessary for cellular energetics.
     In lead  intoxication,  the  presence of both basophilic  stippling  and anemia with a hemo-
lytic component  is due  to inhibition  by  lead of the  activity  of pyrimidine-S'-nucleotidase
(Py-5-N),  an  enzyme  that  mediates  the dephosphorylation  of pyrimidine nucleotides  in  the
maturing erythrocyte.   Inhibition  of this  enzyme by lead has been documented in lead workers,
lead-exposed children, and experimental animal models.   In one study of lead-exposed children,
there was  a  negative  correlation  between  blood  lead  and enzyme activity, with  no  clear  re-
sponse threshold.  A  related report noted  that,  in  addition,  there was a positive correlation
between  cytidine  phosphate and  blood  lead  and  an inverse  correlation between  pyrimidine
nucleotide and enzyme activity.
     The metabolic significance  of Py-5-N  inhibition and cell nucleotide accumulation is that
they affect erythrocyte stability and  survival as well as potentially affect mRNA and protein
synthesis  related to globin chain synthesis.   Based on one study  of  children, the threshold
for the inhibition of Py-5-N activity appears to be about 10 ug/dl blood  lead.  Lead's inhibi-
tion of  Py-5-N  activity and a threshold  for  such inhibition are not by  themselves the issue.
Rather,  the issue is the  relationship  of  such inhibition to a  significant  level of impaired
pyrimidine  nucleotide  metabolism and the  consequences  for erythrocyte stability  and function.
The  relationship  of  Py-5-N  activity  inhibition  by lead  to accumulation of  its  pyrimidine
nucleotide  substrate  is analogous to lead's  inhibition of ALA-D activity and  accumulation of
ALA.
     Tetraethyl  lead  and tetramethyl lead, components  of  leaded gasoline, undergo transforma-
tion  KJ vivo to  neurotoxic trialkyl  metabolites as well  as  further conversion to inorganic
lead.  Hence, one might anticipate that exposure, to  such agents  may result in effects commonly
associated  with  inorganic  lead,  particularly in terms of heme  synthesis and  erythropoiesis.
Various  surveys  and case reports show that the habit of sniffing leaded gasoline  is associated
with  chronic  lead intoxication in children from  socially  deprived  backgrounds  in rural or re-
mote  areas.   Notable in these  subjects is evidence of  impaired heme  biosynthesis, as  indexed
by significantly  reduced ALA-D activity.   In several case  reports  of  frank lead  toxicity  from
habitual  leaded  gasoline  sniffing, effects  such as basophilic  stippling in erythrocytes and
significantly reduced  hemoglobin  have also been  noted.
      The role of lead-associated disturbances  of  heme biosynthesis  as  a possible factor  in
neurological  effects  of lead  is  of considerable  interest due  to  the  following:    (1) simi-
larities between  classical signs  of lead  neurotoxicity and several  neurological  components  of
the congenital  disorder acute  intermittent porphyria;  and (2)  some of the  unusual  aspects  of
lead neurotoxicity.   There are three possible points  of connection  between  lead's effects  on
heme biosynthesis and  the  nervous system.  Associated with both  lead neurotoxicity and acute
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intermittent porphyria is  the  common feature of excessive systemic accumulation and  excretion
of ALA.   In  addition,  lead neurotoxicity reflects, to some degree, impaired synthesis  of heme
and hemoproteins  involved  in  crucial cellular functions;  such an  effect  on heme is  now known
to be relevant within neural tissue as well as in non-neural tissue.
     Available  information indicates  that ALA  levels  are elevated in  the brains  of  lead-
exposed animals and arise through in situ inhibition of brain ALA-D activity or through trans-
port of  ALA to  the  brain  after  formation in  other  tissues.   ALA  is  known  to  traverse  the
blood-brain  barrier.   Hence,  ALA  is accessible to,  or formed within, the  brain  during lead
exposure and may express its neurotoxic potential.
     Based on  various  jn  vitro  and  HI  vivo  neurochemical studies of  lead  neurotoxicity,  it
appears  that ALA can  inhibit  release of the neurotransmitter gamma-aminobutyric  acid (GABA)
from presynaptic  receptors  at  which ALA appears to be very potent even at low levels.  In an
jin vitro  study,  ALA  acted as an agonist at levels as  low as 1.0  uM ALA.  This jn vitro obser-
vation supports  results  of a study  using  lead-exposed rats in which there  was  inhibition  of
both resting and  K -stimulated  release of preloaded 3H-GABA from nerve terminals.  The obser-
vation that  jji  vivo  effects of lead on neurotransmitter function cannot be duplicated  with in
vitro preparations containing added lead is further evidence of an effect of some agent (other
than  lead)   that  acts  directly  on  this  function.   Human data  on  lead-induced  associations
between disturbed heme  synthesis  and neurotoxicity, while  limited,  also  suggest that  ALA may
function as a neurotoxicant.
     A number of  studies  strongly suggest that  lead-impaired  heme production itself may be a
factor in the toxicant's neurotoxicity.  In porphyric  rats, lead  inhibits tryptophan  pyrrolase
activity  owing  to  reductions  in the hepatic  heme  pool,  thereby  leading to elevated  levels of
tryptophan and serotonin in the brain.  Such elevations are known to induce many of the neuro-
toxic effects also seen  with lead exposure.  Of great interest is the fact that heme infusion
in these  animals reduces brain levels  of  these substances and also  restores  enzyme activity
and the  hepatic  heme pool.   Another line of evidence  for the heme-basis of lead neurotoxicity
is that  mouse  dorsal  root ganglion  in culture  manifests morphological  evidence of neural  in-
jury with rather low  lead exposure,  but  such  changes are  largely  prevented  with co-admini-
stration  of  heme.  Finally, studies also show  that heme-requiring cytochrome C production is
impaired along with operation of the cytochrome C respiratory chain in the brain when neonatal
rats are exposed to lead.
     Awareness of the  interactions of lead and  the vitamin D-endocrine system has been grow-
ing.   A  recent study  has found that  children  with blood lead levels  of  33-120  ug/dl showed
significant  reductions in  serum  levels  of  the hormonal metabolite  1,25-dihydroxyvitamin D
(1,25~(OH)2D).   This  inverse  dose-response relationship  was  found  throughout  the  range  of
measured  blood  lead  values, 12-120 ug/dl, and  appeared  to be the result  of lead's  effect on
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the production of  the  vitamin  D hormone.  The 1,25-(OH)2D  levels  of children with blood lead
levels of  33-55  ug/dl  corresponded  to  the  levels that have  been observed  in  children with
severe renal  dysfunction.   At  higher  blood lead  levels (>62 ug/dl), the  1,25-(OH)2D  values
were similar to  those  that have been measured in  children  with various  inborn metabolic dis-
orders.  Chelation therapy of the lead-poisoned children (blood lead levels >62 pg/dl) resulted
in a return to normal 1,25-(OH)2D levels within a short period.
     In  addition  to its well-known  actions on  bone remodeling and  intestinal  absorption of
minerals, the vitamin D hormone has several other physiological actions at the cellular level.
These include  cellular calcium  homeostasis  in  virtually  all  mammalian  cells and associated
calcium-mediated processes  that are  essential  for cellular  integrity and function.   In addi-
tion, the  vitamin  D hormone has newly  recognized  functions  that involve cell differentiation
and  essential  immunoregulatory capacity.   It  is reasonable to  conclude,  therefore,  that im-
paired production  of 1,25-(OH)2D can have profound and pervasive effects on tissues and cells
of diverse type and function throughout  the body.

12.10.4  Neurotoxic Effects of  Lead
     An  assessment of the impact of lead on human and animal neurobehavioral function raises a
number of  issues.   Among the  key  points addressed here are the following:   (1) the internal
exposure levels,  as indexed by blood  lead levels, at which various  neurotoxic effects occur;
(2)  the  persistence or reversibility  of such  effects; and  (3)  populations  that appear to be
most  susceptible to neural  damage.    In addition,  the  question arises  as  to the utility of
using animal studies to draw parallels  to  the human condition.
12.10.4.1   Internal Lead Levels at which  Neurotoxic Effects Occur.   Markedly  elevated blood
lead  levels  are  associated with the most  serious  neurotoxic effects  of lead exposure (includ-
ing  severe,  irreversible brain  damage  as indexed by the  occurrence  of acute or chronic  enceph-
alopathic  symptoms,  or both) in both  humans  and animals.   For  most  adult humans, such damage
typically  does  not occur until  blood  lead levels  exceed 120 ug/dl.   Evidence  does exist,  how-
ever, for  acute  encephalopathy and death  occurring  in some human  adults at blood lead as low
as  100   ug/dl.   In children,  the  effective blood lead  level  for producing encephalopathy or
death  is  lower, starting  at approximately 80-100 ug/dl.   It  should be  emphasized that,  once
encephalopathy occurs,  death is not an improbable outcome,  regardless of the  quality of  medi-
cal  treatment available at the  time of acute crisis.   In fact, certain diagnostic  or treatment
procedures themselves  may exacerbate  matters  and  push the  outcome toward  fatality if the
nature and severity of the  problem are not diagnosed  or fully recognized.   It is  also  crucial
to  note  the rapidity with  which acute encephalopathic symptoms can develop or death can occur
in  apparently asymptomatic individuals or in those apparently  only mildly affected by  elevated

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lead body  burdens.   Rapid deterioration  often  occurs,  with convulsions or coma suddenly  ap-
pearing  with  progression  to death  within  48  hours.   This  strongly  suggests  that even  in
apparently asymptomatic individuals,  rather severe neural damage probably exists  at high  blood
lead levels even  though  it is not yet overtly manifested in obvious encephalopathic symptoms.
This conclusion is further supported by numerous studies showing that overtly lead  intoxicated
children with high blood lead levels, but not observed to manifest acute encephalopathic  symp-
toms, are permanently cognitively impaired, as are most children who survive acute  episodes of
frank lead encephalopathy.
     Recent studies  show that overt  signs  and  symptoms of neurotoxicity (indicative of both
CNS and peripheral nerve dysfunction) are detectable in some human adults at blood  lead  levels
as  low  as 40-60 ug/dl, levels well  below blood lead concentrations previously thought  to be
"safe" for adult  lead  exposures.   In addition,  certain  electrophysiological  studies  of  peri-
pheral nerve function  in  lead workers indicate  that slowing of nerve conduction  velocities in
some peripheral  nerves is associated with  blood  lead  levels  as low as 30-50 ug/dl  (with no
clear threshold for  the  effect  being evident).   These  results  are  indicative of neurological
dysfunctions occurring at  relatively low lead levels in  non-overtly  lead-intoxicated adults.
     Other evidence  confirms  that  neural  dysfunctions exist in  apparently  asymptomatic  chil-
dren at  similar or  even lower levels of blood lead.  The body of studies on low- or moderate-
level lead effects  on  neurobehavioral functions in non-overtly  lead-intoxicated children,  as
summarized in  Table 12-2, presents  an array of  data  pointing  to that conclusion.  At high
exposure  levels,  several  studies  point  toward  average 5-point  IQ  decrements  occurring  in
asymptomatic children at average blood levels of 50-70 ug/dl.   Other evidence is  indicative of
average  IQ  decrements  of about 4 points  being  associated with blood levels  in  a  30-50  ug/dl
range.  Below 30 ug/dl, the evidence for IQ decrements is quite mixed, with  some  studies  show-
ing  no   significant  associations  with  lead  once other  confounding  factors are  controlled.
Still, the  1-2 point differences  in IQ  generally  seen with  blood lead levels  in  the 15-30
ug/dl range  are suggestive of lead  effects  that  are often dwarfed by  other socio-hereditary
factors.   Moreover,  a  highly significant  linear  relationship  between IQ and blood lead over
the range of 6 to 47 ug/dl  found  in low-SES Black children indicates  that  IQ effects may be
detected without  evident  threshold even at  these  low levels,  at least in this  population of
children.  In  addition,  other behavioral  (e.g.,  reaction time,  psychomotor  performance)  and
electrophysiological (altered EEG  patterns,  evoked potential  measures, and  peripheral  nerve
conduction velocities)  are consistent with  a dose-response function relating neurotoxic  ef-
fects to lead  exposure  levels  as  low as  15-30 ug/dl and possibly lower.   Although  the com-
parability of  blood lead  concentrations  across species is uncertain (see  discussion below),
studies  show  neurobehavioral effects in  rats and monkeys at maximal blood  lead levels  below

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20 ug/dl;  some studies demonstrate  residual  effects long after lead  exposure  has  terminated
and blood lead levels have returned to approximately normal levels.
     Timing, type,  and duration  of  exposure are  important factors in both  animal  and  human
studies.   It is often  uncertain whether observed blood  lead  levels represent the levels that
were responsible for observed behavioral deficits or electrophysiological  changes.   Monitoring
of lead  exposures in  pediatric subjects in  all  cases  has  been highly  intermittent  or non-
existent during the  period  of life preceding neurobehavioral  assessment.   In most studies of
children, only one  or  two blood lead values  are  provided per subject.  Tooth  lead  may  be an
important  cumulative exposure  index,  but  its  modest,  highly variable correlation to  blood
lead, FEP,  or  external  exposure levels makes findings  from various studies difficult to com-
pare  quantitatively.   The complexity  of the many  important  covariates and their interaction
with dependent variable measures of modest validity, e.g., IQ  tests, may also account for many
of the discrepancies among the different studies.
12.10.4.2  Jhe Question of Irreversibility.   Little  research on humans is available on persis-
tence of effects.   Some work suggests that mild forms of peripheral neuropathy in lead workers
may be reversible after termination of  lead exposure, but  little is known regarding the rever-
sibility of  lead  effects  on central  nervous  system function  in humans.  A two-year follow-up
study of 28 children of battery factory workers found a continuing relationship between blood
lead  levels  and  altered slow wave voltage of cortical slow wave potentials indicative of per-
sisting CNS  effects  of lead, and  a  five-year follow-up of some of the same children revealed
the  presence of  altered  brain stem auditory evoked potentials.   Current population studies,
however, will  have  to be  supplemented  by  longitudinal  studies  of  the effects of  lead on
development  in order to address  the  issue  of the  reversibility or persistence  of the neuro-
toxic effects  of  lead in humans  more  satisfactorily.   (See the Addendum to this document for
a  discussion of  recent  results from  prospective  studies  linking  perinatal  lead exposure to
postnatal mental  development.)
      Various animal  studies provide evidence that  alterations in neurobehavioral function may
be long-lived,  with such  alterations being evident long after blood lead levels have returned
to control  levels.   These persistent  effects  have been demonstrated in monkeys as well as rats
under a variety of  learning performance test  paradigms.  Such  results  are also consistent with
morphological,  electrophysiological,  and biochemical  studies  on animals  that suggest lasting
changes  in  synaptogenesis,  dendritic  development,  myelin  and fiber  tract  formation,   ionic
mechanisms  of  neurotransmission,  and  energy metabolism.
12.10.4.3    Early Development  and  the Susceptibility to  Neural Damage.    On  the  question   of
early childhood vulnerability, the neurobehavioral  data are  consistent with  morphological  and
biochemical  studies of the susceptibility  of the  heme biosynthetic pathway to  perturbation by
lead.  Various  lines of evidence  suggest that the  order  of susceptibility to  lead's  effects is
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as  follows:   (1) young  > adults and (2) female >  male.   Animal  studies also have pointed  to
the perinatal  period of  ontogeny  as a particularly  critical  time for a variety of  reasons:
(1) it  is  a  period of rapid development of  the  nervous system;  (2)  it  is  a period when good
nutrition  is  particularly  critical;  and  (3)  it is  a  period  when the caregiver  environment  is
vital  to normal development.   However,  the  precise boundaries of  a critical  period are not yet
clear and  may vary depending on the species and  function  or endpoint that  is being assessed.
One analysis of lead-exposed children suggests  that differing effects on cognitive performance
may be  a  function  of the different ages at  which children are subjected to  neurotoxic  expo-
sures.  Nevertheless, there is general  agreement  that human infants and toddlers below the age
of  three  years are  at  special risk because of jji utero exposure  (see Addendum),  increased
opportunity  for  exposure because  of normal  mouthing behavior,  and  increased  rates  of  lead
absorption due to various factors,  e.g.,  nutritional deficiences.
12.10.4.4     Utility of Animal Studies in  Drawing Parallels  to the Human Condition.     Animal
models  are used  to shed light on questions  where  it  is impractical  or ethically unacceptable
to  use  human  subjects.    This  is  particularly true in the case of  exposure  to environmental
toxins  such  as lead.   In  the case  of lead,  it  has  been effective and convenient to  expose
developing animals  via  their mothers'  milk or by  gastric  gavage,  at least  until weaning.   In
many  studies,  exposure was  continued in  the  water or food for some time beyond  weaning.   This
approach  simulates  at least two features  commonly found in  human exposure:  oral intake and
exposure  during  early development.   The preweaning period in  rats and mice  is  of particular
relevance  in  terms of parallels  with  the first  two  years or so of  human  brain development.
     Studies  using  rodents and monkeys have  provided a variety of evidence  of neurobehavioral
alteration  induced by  lead  exposure.    In  most  cases  these  effects  suggest   impairment  in
"learning," i.e.,  the process  of  appropriately modifying one's behavior in  response to infor-
mation  from  the environment.   Such  behavior  involves  the ability  to receive, process, and
remember information in  various forms.   Some  studies indicate behavioral  alterations of a more
basic type, such as delayed  development  of certain reflexes.   Other evidence suggests changes
affecting rather complex behavior  in  the  form of  social interactions.
     Most of  the above  effects are evident  in rodents  and monkeys with blood lead levels ex-
ceeding 30 (jg/dl > but some effects  on learning  ability are apparent even at  maximum blood lead
exposure  levels  below 20 ug/dl.   Can  these results  with animals  be generalized  to  humans?
Given differences  between  humans,  rats,  and  monkeys  in  heme  chemistry,  metabolism, and other
aspects of  physiology and anatomy,  it is difficult  to state what  constitutes  an equivalent
internal exposure  level  (much  less  an  equivalent external  exposure level).   For example, is a
blood  lead  level  of  30  ug/dl  in  a  suckling  rat  equivalent to  30  ug/dl in  a  three-year-old
child?  Until  an answer is  available  for  this question, i.e., until  the function describing

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the relationship of  exposure  indices in different species is available,  the utility of animal
models for deriving dose-response functions relevant to humans will be limited.
     Questions also  exist regarding  the  comparability of neurobehavioral  effects  in animals
with human behavior  and cognitive function.  One difficulty in comparing behavioral endpoints
such as locomotor activity is the lack of a consistent operational definition.  In addition to
the lack  of  standardized methodologies, behavior is notoriously difficult to "equate" or com-
pare meaningfully  across species  because  behavioral analogies do not demonstrate  behavioral
homologies.  Thus, it is improper to assume, without knowing more about the responsible under-
lying neurological structures and processes, that a rat's performance on an operant condition-
ing schedule or a  monkey's  performance on a  stimulus  discrimination task  corresponds  to a
child's  performance on  a cognitive function  test.   Nevertheless,  interesting  parallels in
hyper-reactivity  and increased  response  variability do  exist  between different species, and
deficits  in  performance on various  tasks  are indicative of  altered  CMS  functions, which are
likely to parallel some  type of  altered CNS function in humans as  well.
     In  terms of  morphological  findings,  there  are reports  of   hippocampal lesions  in both
lead-exposed rats and humans that are consistent with a number of  behavioral  findings suggest-
ing an  impaired  ability to  respond appropriately  to  altered contingencies for rewards. That
is, subjects tend to persist in  certain patterns of behavior  even  when changed  conditions make
the behavior inappropriate.    Other  morphological  findings  in  animals,  such as demyelination
and glial  cell  decline, are comparable  to human neuropathologic  observations  mainly at  rela-
tively high  exposure levels.
     Another neurobehavioral  endpoint of  interest  in  comparing human and  animal neurotoxicity
of lead  is electrophysiological  function.   Alterations  of electroencephalographic patterns and
cortical  slow wave  voltage have been reported  for  lead-exposed children,  and various electro-
physiological  alterations both  i_n vivo  (e.g.,  in  rat  visual  evoked response)  and JQ  vitro
(e.g.,  in frog miniature endplate potentials)  have also  been noted in laboratory animals.  At
this  time, however, these lines of  work  have  not  converged  sufficiently to allow for  strong
conclusions  regarding  the electrophysiological  aspects  of lead  neurotoxicity.
      Biochemical  approaches  to  the  experimental  study of lead's  effects  on the nervous  system
have  generally been limited to  laboratory animal  subjects.   Although their linkage to  human
neurobehavioral  function  is  at this point somewhat speculative,  such studies do  provide  in-
sight to possible neurochemical  intermediaries  of lead  neurotoxicity.  No  single  neurotrans-
mitter  system  has  been  shown  to be particularly  sensitive  to the  effects  of lead  exposure;
 lead-induced alterations have been  demonstrated in various neurotransmitters,  including dopa-
 mine,  norepinephrine,  serotonin, and y-aminobutyric acjd.  In addition,  lead has been shown to
 have  subcellular effects  in  the central nervous system at the level of mitochondrial function
 and protein synthesis.
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     Given the above-noted  difficulties  in  formulating a comparative  basis  for  internal  expo-
sure levels among different species,  the primary value of many animal  studies, particularly  in
vitro studies, may be in the information they can provide on basic  mechanisms  involved  in lead
neurotoxicity.  A  number of jm  vitro  studies show that  significant, potentially  deleterious
effects on nervous  system  function occur at j_n  situ  lead concentrations  of 5 pM and possibly
lower, suggesting that  no  threshold  may exist for certain  neurochemical  effects of lead on a
subcellular or molecular level.   The relationship between blood lead levels  and lead  concen-
trations at such  extra- or intracellular sites  of action,  however,  remains to  be  determined.
Despite the  problems in generalizing  from animals to  humans,  both  the animal  and the  human
studies show  great  internal  consistency in that they  support a continuous dose-response  func-
tional  relationship between  lead and  neurotoxic biochemical, morphological,  electrophysio-
logical, and behavioral  effects.

12.10.5  Effects of Lead on the Kidney
     It  has  been  known for  more than  a century that  kidney disease can result from lead
poisoning.  Identifying the contributing causes and mechanisms of  lead-induced nephropathy has
been  difficult,  however,  in part because of  the complexities of  human exposure  to lead and
other nephrotoxic agents.   Nevertheless, it is possible to estimate at least roughly the  range
of  lead exposure  associated with detectable renal dysfunction  in  both  human  adults and  chil-
dren.   Numerous  studies of  occupationally  exposed workers  have  provided  evidence for  lead-
induced chronic  nephropathy being associated  with blood lead levels  ranging  from 40  to more
than 100 M9/dl» and some  are suggestive of renal effects possibly  occurring even at levels as
low as 30 ug/dl.  In children,  the relatively sparse evidence available  points to the manifes-
tation of  nephropathy only at  quite high blood  lead levels (usually exceeding 100-120  ug/dl).
The current lack of evidence for nephropathy at lower  blood lead levels  in children may simply
reflect the greater clinical concern with neurotoxic  effects of lead  intoxication  in children
or, possibly,  that  much longer-term  lead exposures are  necessary  to  induce nephropathy.  The
persistence of lead-induced nephropathy  in  children  also  remains to be more  fully investi-
gated, although a  few  studies  indicate that children  diagnosed as  being acutely lead poisoned
experience lead nephropathy effects lasting throughout adulthood.
     Parallel  results  from experimental  animal  studies reinforce  the findings in humans and
help  illuminate  the mechanisms  underlying  such  effects.   For example,  a number of transient
effects  in human and animal renal function  are consistent with experimental  findings of re-
versible  lesions  such  as   nuclear  inclusion  bodies,  cytomegaly,   swollen  mitochondria,  and
increased numbers of iron-containing lysosomes in proximal tubule  cells.   Irreversible  lesions
such  as  interstitial fibrosis are also  well  documented in both humans and animals  following

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chronic exposure to high doses of lead.   Functional  renal  changes observed in humans  have also
been confirmed  in  animal  model  systems  with respect to increased excretion of amino  acids and
elevated serum  urea nitrogen and  uric  acid  concentrations.   The inhibitory effects  of lead
exposure on renal blood flow and glomerular filtration rate are currently less clear  in exper-
imental model  systems; further  research  is  needed  to clarify  the  effects of  lead  on these
functional  parameters  in animals.   Similarly,  while  lead-induced perturbation  of the renin-
angiotensin  system has been  demonstrated  in experimental animal models,  further  research is
needed to  clarify  the  exact relationships among lead exposure (particularly chronic  low-level
exposure),  alteration  of the  renin-angiotensin system,  and  hypertension in both humans and
animals.
     On the  biochemical  level,  it appears that  lead  exposure produces changes at a  number of
sites.   Inhibition of  membrane marker enzymes,  decreased mitochondria!  respiratory  function/
cellular energy production,  inhibition  of renal heme  biosynthesis,  and  altered nucleic acid
synthesis  are  the  most marked changes to have been reported.  The extent to which these mito-
chondrial  alterations  occur is  probably mediated in part by the intracellular bioavailability
of  lead,  which  is determined by  its  binding to high-affinity  kidney cytosolic proteins and
deposition within  intranuclear inclusion bodies.
     Among the  questions remaining to be answered more definitively  about the effects of lead
on the kidneys  is  the  lowest  blood lead level at which renal  effects  occur.  In this regard it
should be  noted that recent  studies in  humans  have indicated that the EDTA lead-mobilization
test  is  the most  reliable technique  for detecting persons  at  risk for chronic nephropathy;
blood  lead  measurements  are  a  less  satisfactory  indicator  because they  may  not accurately
reflect  cumulative absorption  some  time after exposure  to  lead has terminated.  Other ques-
tions  include the  following:  Can a distinctive  lead-induced  renal lesion be identified  either
in  functional  or  histologic  terms?  What  biologic  measurements  are most  reliable for the pre-
diction of lead-induced  nephropathy?  What  is the incidence of lead  nephropathy  in the  general
population as well as  among specifically defined  subgroups with  varying exposure?  What  is the
natural  history of  treated and  untreated  lead nephropathy?  What  is the mechanism of  lead-
induced  hypertension  and  renal injury?   What  are   the  contributions  of  environmental and
genetic  factors to the appearance of renal  injury due  to  lead?   Conversely,  the  most  difficult
question of  all may well  be  to determine the  contribution  of  low levels of lead exposure to
possible exacerbation  of renal  disease  of  non-lead  etiologies.

12.10.6  Effects of Lead on Reproduction  and Development
      The  most  clear-cut data described  in  this section on reproduction and development are
derived from studies  employing  high  lead doses in laboratory animals.   There is still a need
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for more critical research to evaluate the possible subtle toxic effects of lead  on  the fetus,
using  biochemical,  ultrastructural,  or behavioral  endpoints.   An  exhaustive evaluation  of
lead-associated changes in  offspring  should include consideration of possible effects  due  to
paternal lead burden  as  well.   Neonatal lead intake via consumption of  milk from lead-exposed
mothers may also be a factor at times.  Moreover, it must be recognized  that lead's  effects  on
reproduction  may be  exacerbated  by  other environmental  factors  (e.g.,  dietary  influences,
maternal hyperthermia, hypoxia, and co-exposure to other toxins).
     There are  currently  no reliable  data pointing to adverse effects in human offspring fol-
lowing  lead  exposure  of  fathers  per  se.   Early  studies  of pregnant  women exposed to  high
levels of lead indicated toxic, but not teratogenic, effects on the conceptus.   Unfortunately,
the  collective  human data  regarding  lead's effects  on reproduction or  rn  utero  development
currently  do  not  lend  themselves to  accurate  estimation  of  exposure-effect  or  no-effect
levels.  This  is particularly  true  regarding effects  on reproductive  performance  in  women,
which  have  not  been well  documented at  low  exposure  levels.   Still,  prudence would  argue
for  avoidance  of  lead exposures  resulting in  blood  lead levels  exceeding  25-30 ug/dl  -jn
pregnant women  or  women of  child-bearing age  in general,  given the  equilibration  between
maternal and  fetal  blood lead  concentrations  that occurs and the growing evidence  for dele-
terious effects  in  young children as b'lood lead levels approach or  exceed  25-30 ug/dl.   In-
dustrial exposure of  men  to lead at levels resulting in blood lead values of 40-50  ug/dl also
appear to result in altered testicular function.
     The paucity of  human exposure data forces an examination of the animal  studies for indi-
cations of threshold  levels for effects of lead  on the conceptus.  It  must be noted that the
animal  data  are almost entirely derived from  rodents.   Based on these  rodent data,  it seems
likely  that  fetotoxic effects  have  occurred  in  animals at chronic  exposures to 600-800 ppm
inorganic lead  in the diet.  Subtle effects appear to  have been observed at  5-10  ppm in the
drinking water, while effects of inhaled lead have been seen at levels of 10 mg/m3.   With mul-
tiple  exposure  by gavage,  the   lowest observed effect level is 64 mg/kg  per day,  and for expo-
sure via injection,  acute doses of 10-16 mg/kg appear effective.   Since  humans  are most likely
to be exposed to lead in their diet, air, or water, the data from other  routes  of exposure are
of  less value  in estimating harmful  exposures.   Indeed,  it appears  that teratogenic  effects
occur  in experimental animals only when the maternal dose is given by injection.
     Although human and  animal  responses may be dissimilar, the animal  evidence does document
a variety of  effects  of lead exposure  on  reproduction  and development.  Measured or apparent
changes  in  production of or response  to reproductive hormones, toxic effects on  the  gonads,
and  toxic  or teratogenic  effects  on the  conceptus have all been  reported.   The  animal data
also suggest subtle effects on  such parameters as metabolism and cell structure that should be
monitored  in  human  populations.   Well-designed  prospective  human epidemiological  studies
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involving large  numbers  of subjects  are still  needed  (beyond the few  currently  available).
Such data  could  clarify the  relationship of exposure periods, exposure durations,  and  blood
lead concentrations associated with  significant  effects and are needed  for  estimation of no-
effect levels as well.   (Recent  studies, most of which  are prospective epidemiological inves-
tigations,  on the relationship between relatively low-level lead exposure and effects on fetal
and  child  development,  along with  supporting experimental  evidence  on possible  underlying
mechanisms, are reviewed in an Addendum to this document.)

12.10.7  Genotoxic and Carcinogenic Effects  of Lead
     It is difficult  to  conclude what role  lead may play in the induction of human neoplasia.
Epidemiological studies of lead-exposed workers provide no definitive findings.   However, sta-
tistically significant elevations  in  cancer of the  respiratory  tract  and digestive system in
workers exposed  to  lead  and other agents warrant  some  concern.   Since  it is clear that lead
acetate can produce renal tumors in some experimental animals, it seems reasonable to conclude
that at  least  this  particular lead compound should be regarded as a carcinogen and prudent to
treat  it as  if it were also  a  human  carcinogen (as concluded by the International Agency for
Research on  Cancer).   However,  this statement is  qualified by noting that lead has been seen
to  increase  tumorigenesis  rates  in animals only at relatively high concentrations, and there-
fore does  not  seem to be a potent carcinogen.  Jin vitro studies further support the genotoxic
and  carcinogenic role of  lead,  but also indicate that lead  is not potent  in  these systems.

12.10.8  Effects of Lead on the  Immune System
     Lead  renders  animals  more susceptible to endotoxins  and  infectious agents.  Host suscep-
tibility and  the humoral  immune system  appear to  be particularly sensitive.   As postulated in
recent  studies,  the  macrophage  may  be the  primary  immune  target  cell  of lead.  Lead-induced
immunosuppression  occurs  in experimental animals  at  low  lead  exposures  that, although not in-
ducing overt toxicity, may  nevertheless  be  detrimental  to  health.  Available data provide good
evidence  that lead affects immunity, but  additional  studies  are  necessary to elucidate the
actual mechanisms by  which  lead  exerts its  immunosuppressive action.   Knowledge of  the effects
of  lead  on the  human  immune  system is  lacking and  must  be ascertained in order to  determine
permissible  levels for  human exposure.   However,  in view of  the  fact that lead  affects im-
munity in  laboratory  animals and  is  immunosuppressive  at very  low dosages,  its potential for
serious  effects  in  humans  should be carefully considered.

12.10.9  Effects of Lead on Other  Organ  Systems
      The cardiovascular, hepatic,  gastrointestinal,  and endocrine  systems generally show signs
of  dysfunction mainly at relatively  high lead exposure  levels.   Consequently,  in  most clinical
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and experimental  studies,  attention has been primarily focused  on  more sensitive and vulner-
able  target  organs,  such as the  hematopoietic  and nervous systems.  However,  some  work does
suggest that humans and animals show significant increases in blood pressure following chronic
exposure to low levels of lead (see Addendum to this document for a detailed discussion of the
relationship  between  blood  lead and  blood pressure and  the possible  biological  mechanisms
which may  be  responsible  for this association).  It should also be noted that overt gastroin-
testinal  symptoms associated  with  lead  intoxication  have  been  observed to  occur  in lead
workers at blood  lead levels as  low as 40-60 M9/dl-   These findings suggest that  effects  on
the gastrointestinal  and  cardiovascular systems may occur at  relatively low  exposure levels,
but remain to be more conclusively demonstrated by further scientific investigations.   Current
evidence indicates that various endocrine processes may be affected by lead at relatively high
exposure  levels.   Little  information  exists  on endocrine  effects  at  lower  exposure levels,
except  for alterations  in vitamin-D metabolism previously discussed as secondary to heme syn-
thesis  effects  and occurring  at blood  lead  levels ranging  below  30 ug/dl  to as  low  as  12
ug/dl.   (Evidence relating  endocrine function to  various recently  reported  lead-associated
effects on human  fetal and  child  development,  including effects  on growth and  stature,  is
reviewed in the Addendum to this document.)
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12.11  REFERENCES


Abbott,  W.  S.  (1925) A  method  of computing  the effectiveness  of an  insecticide.  J.  Econ.
     Entomol.  18: 265-267.

Abdulla,  M.;  Haeger-Aronsen,  B.;  Svensson,  S.  (1976) Effect  of  ethanol  and  zinc  on ALA-
     dehydratase activity in red blood cells. Enzyme 21: 248-252.

Adams,  N.;  Boice, R.  (1981)  Mouse (Mus) burrows: effects  of  age,  strain, and domestication.
     Anim. Learn. Behav.  9: 140-144.

Adebonojo, F. 0.  (1974) Hematologic status  of  urban black children  in  Philadelphia: emphasis
     on  the frequency of anemia and elevated blood  lead levels.  Clin. Pediatr. (Philadelphia)
     13: 874-888.

Agerty,  H. A.  (1952)  Lead poisoning in children.  Med.  Clin. North Am.  36:  1587-1597.

Ahlberg,  J.;   Ramel,   C.;  Wachtmeister,  C.   A.   (1972)   Organolead compounds  shown  to   be
     genetically  active.  Ambio 1:  29-31.

Albahary, C.  (1972)  Lead and hemopoiesis:  the  mechanism and  consequences  of the erythropathy
     of  occupational  lead poisoning. Am.  J.  Med.  52:  367-378.

Albahary,  C.;  Truhant,  R.;  Boudene, C.;  Desoille, H.  (1961) Le  depistage  de  1'impregnation
     saturnine  par  un test de mobilisation  du  plomb  [A case  study of lead uptake from  a test
     for lead mobilization].  Presse Med.  69:  2121-2123.

Albahary,  C.; Richet, G.; Guillaume, J.;  Morel-Maroger,  L. (1965)  Le rein dans  le saturnisme
     professional [The kidney during occupational lead poisoning].  Arch. Mai.  Prof.  Med. Trav.
     Secur. Soc.  26:  5-19.

Alessio, L.;  Bertazzi, P. A.; Monelli,  0.;  Foa,  V.  (1976a) Free erythrocyte protoporphyrin as
     an  indicator of the biological effect of lead in adult males.  II. Comparison between  free
     erythrocyte protoporphyrin  and  other  indicators  of   effect.  Int.  Arch. Occup.  Environ.
     Health 37:  89-105.

Alessio, L.; Bertazzi, P. A.;  Monelli, 0.;  Toffoletto,   F.  (1976b) Free  erythrocyte  proto-
     porphyrin  as an  indicator  of the  biological effect of lead in adult males.  III.  Behavior
     of free  erythrocyte protoporphyrin  in  workers with past lead exposure. Int. Arch.  Occup.
     Environ. Health 38:  77-86.

Alessio, L.;  Castoldi, M. R.;  Monelli,  0.;  Toffoletto, F.; Zocchetti, C. (1979) Indicators of
      internal dose  in current and past  exposure to lead.  Int.  Arch. Occup. Environ. Health 44:
     127-132.

Alexander,  F. W.; Delves, H.  T.  (1981) Blood  lead  levels  during pregnancy. Int. Arch.  Occup.
      Environ. Health 48:  35-39.

Alfano,  D.  P.;  Petit, T.  L.  (1982) Neonatal lead exposure alters the dendritic  development of
      hippocampal dentate granule cells.  Exp. Neurol. 75:  275-288.
                                           12-291

-------
Alfano,  D.   P.;  Petit,  T.   L.  (1985)  Postnatal  lead  exposure  and  the  cholinergic system.
     Physiol. Behav. 34: 449-455.

Alfano,  D.   P.;  LeBoutiTlier,  J.  C.;  Petit,  T.  L.  (1982)  Hippocampal  mossy  fiber pathway
     development in normal and postnatally lead-exposed rats. Exp. Neurol. 75: 308-319.

Allen, J. R.; McWey, P. J.; Suomi, S. J. (1974) Pathobiological and behavioral effects of  lead
     intoxication in the infant rhesus monkey.  Environ. Health Perspect. 7: 239-246.

Alvares, A.  P.;  Leigh,  S.;  Cohn, J.;  Kappas,  A.  (1972) Lead and  methyl  mercury:  effects  of
     acute exposure on cytochrome P-450 and the mixed function oxidase  system  in the  liver.  J.
     Exp. Med. 135: 1406-1409.

Alvares, A.   P.; Kapelner, S.; Sassa,  S.; Kappas, A.  (1975) Drug metabolism in  normal  children,
     lead-poisoned children,  and normal adults. Clin. Pharmacol.  Ther.  17: 179-183.

Alvares, A.  P.;  Fischbein, A.;  Sassa,  S.;  Anderson, K. E.;  Kappas,  A. (1976) Lead  intoxica-
     tion:  effects on cytochrome P-450-mediated hepatic oxidations. Clin.  Pharmacol.  Ther.  19:
     183-190.

Angel!,  N.  F. ; Weiss,  B.  (1982)  Operant  behavior  of  rats   exposed  to lead  before  or after
     weaning. Toxicol. Appl.  Pharmacol. 63: 62-71.

Angle,  C.   R.;  Mclntire,  M.  S. (1964)  Lead poisoning  during pregnancy: fetal  tolerance  of
     calcium  disodium edetate. Am. J. Dis. Child. 108: 436-439.

Angle, C. R. ; Mclntire,  M.  S.  (1978)  Low  level lead and inhibition of erythrocyte pyrimidine
     nucleotidase.  Environ. Res. 17: 296-302.

Angle,  C.   R.;  Mclntire,  M.  S. (1982)  Children,  the  barometer of  environmental  lead   Adv
     Pediatr. 27: 3-31.

Angle, C. R. ; Mclntire,  M.  S. ; Swanson, M. S.; Stohs, S. J.  (1982) Erythrocyte nucleotides in
     children  -  increased blood  lead and  cytidine  triphosphate.  Pediatr.  Res.  16:  331-334.

Anku,  V.  D.;  Harris,  J.  W.   (1974)  Peripheral  neuropathy and lead poisoning in  a child  with
     sickle-cell anemia. J. Pediatr.  (St. Louis) 85: 337-340.

Anonymous.   (1966)  Nephropathy in chronic lead  poisoning  [editorial].  J.  Am.  Med. Assoc.  197-
     722.

Araki, S.;  Honma, T. (1976) Relationships between lead absorption and peripheral nerve conduc-
     tion velocities in lead workers. Scand.  J. Work. Environ. Health 4:  225-231.

Araki,  S.;  Honma,   T.;  Yanagihara,  S.;  Ushio,  K.  (1980)  Recovery  of  slowed  nerve conduction
     velocity in lead-exposed workers. Int. Arch. Occup. Environ. Health 46:  151-157.

Araki,  S. ;  Murata, K.;  Yanagihara,  S. ;  Ushio, K.  (1982) High  medical consultation  rates  of
     lead workers  after  industrial dispute over lead  effects.  Int. Arch. Environ. Health 49:
     241-250.

Arnvig,  E.;  Grandjean,  P.;   Beckmann,  J.  (1980)  Neurotoxic effects  of  heavy  lead  exposure
     determined with psychological tests. Toxicol. Lett. 5: 399-404.


                                          12-292

-------
Ashby, J. A.  S.  (1980) A neurological  and  biochemical  study of early  lead poisoning.  Br. J.
     Ind. Med. 37: 133-140.

Asokan,  S.  K.  (1974)  Experimental lead cardiomyopathy:  myocardial  structural  changes in  rats
     given small amounts of lead. J. Lab.  Clin. Med. 84: 20-25.

Atchison, W.  D.;  Narahashi,  T.  (1984) Mechanism of action of lead on neuromuscular junctions.
     Neurotoxicology 5: 267-282.

Aub, J.  C.;  Reznikoff, P.  (1924)  Lead  studies.  Ill:  The effects  of lead in red  blood cells.
     Part 3: a chemical explanation of the reaction of  lead with red blood  cells.  J.  Exp.  Med.
     40: 189-208.

Aub, J.  C.;  Fairhall,  L.  T.; Minot, A. S.; Reznikoff,  P.; Hamilton, A.  (1926)  Lead poisoning,
     with  a  chapter  on  the  prevalence  of  industrial  lead  poisoning  in  the  United States.
     Baltimore, MD: The Williams  and Wilkins Company.  (Medicine monographs:  v.  7).

Averill,  D.  R. ,  Jr.;  Needleman,  H. L.  (1980)  Neonatal  lead  exposure retards cortical synapto-
     genesis  in  the  rat.  In:  Needleman, H.  L. ,  ed.  Low  level   lead  exposure:   the clinical
      implications of current  research.  New York, NY:  Raven Press;  pp.  201-210.

Aviv,  A.; John,  E.;  Bernstein,  J.;  Goldsmith, D.  I.; Spitzer,  A.  (1980) Lead  intoxication
     during  development:  its  late effects on  kidney function and blood pressure. Kidney Int.
     17:  430-437.

Azar,  A.;  Trochimowicz,  H.  J.;  Maxfield,  M.  E.  (1973) Review  of  lead  studies in animals
     carried  out at  Haskell  Laboratory:  two  year  feeding  study and  response to  hemraorhage
     study.  In:  Barth, D. ; Berlin,  A.;  Engel, R. ;  Recht,  P.; Smeets,  J.,  eds.  Environmental
      health  aspects of  lead:  proceedings,  international  symposium; October 1972;  Amsterdam,
     The Netherlands.  Luxembourg:  Commission of the European Communities; pp.  199-210.

Bach,  F. H.; Bach, M.  L.;  Sondel, P.  M.  (1976)  Differential function  of  major  histocompati-
      bility complex antigens  in T-lymphocyte activation. Nature  (London) 259:  273-281.

Badawy,  A.  A.-B.  (1978) Tryptophan pyrrolase,  the  regulatory free  haem and  hepatic porphyrias:
      early  depletion  of haem by  clinical and  experimental  exacerbators of  porphyria. Biochem.
      J.  172:  487-494.

Baker,  E.  L., Jr.; Landrigan,  P.  J.;  Barbour, A.  G.; Cox,  D.  H.;  Folland,  D.  S.;  Ligo,  R. N.;
      Throckmorton,  J.  (1979)  Occupational  lead poisoning  in the United States:  clinical and
      biochemical  findings  related to  blood  lead levels. Br.  J.  Ind.  Med. 36: 314-322.

Baker,  E.  L.; Goyer,  R.  A.;  Fowler,  B.  A.; Khettry, U.; Bernard, D.  B.; Adler,  S.; White, R.
      D.; Babayan,  R.;  Feldman,  R.  G.  (1980)  Occupational lead exposure, nephropathy, and  renal
      cancer.  Am.  J.  Ind.  Med.  1:  139-148.

Baker,  E.  L.; Feldman, R.  G.; White,  R. F.;  Harley, J. P. (1983) The role of occupational  lead
      exposure in  the genesis  of  psychiatric and behavioral  disturbances.   Acta   Psychiatr.
      Scand.  Suppl.  67:  38-48.

Baker,  E.  L.; Feldman, R.  G.; White,  R. A.;  Harley, J. P.; Niles, C. A.; Dinse, G. E.; Berkey,
      C.   S.  (1984) Occupational   lead  neurotoxicity:  a behavioural  and  electrophysiological
      evaluation:  study design and year one results. Br. J. Ind.  Med. 41: 352-361.


                                           12-293

-------
Baldwin,  R.  W.;  Cunningham.  G. J.;  Pratt,  D.  (1964) Carcinogenic  action  of motor engine oil
     additives. Br. J. Cancer 18: 503-507.

Ball, G.  V.;  Sorensen,  L.  B. (1969) Pathogenesis of hyperuricemia  in saturnine gout. N.  Engl.
     J.  Med. 280: 1199-1202.

Bald,  J.;  Bajtai,  A.;  Szende,  B.  (1965)  Chronicus  dlomphosphat  kezele"ssel  le"trehozott
     Riserletes  veseadenomak  [Experimental  adenomas  of  the  kidney  produced  by  chronic
     administration of lead phosphate]. Magyar Onkol. 9:  144-151.

Baloh,  R.  W.;  Spivey,  G.  H.;  Brown, C.  P.;  Morgan,  D.;  Campion,  D.  S.;  Browdy,  B. L.;
     Valentine,  J.  L.;  Gonik,  H.  C.;  Massey,  F. J.,  Jr.; Culver,  B.  D. (1979) Subclinical
     effects  of  chronic  increased lead absorption—a prospective  study.  II. Results of  base-
     line neurologic testing. J. Occup. Med. 21: 490-496.

Bar-Shavit,  Z.;  Noff, D.;  Edelstein,  S.;  Meyer,  M.;  Shibolet, S.;  Goldman, R.  (1981)  1,25-
     dihydroxyvitamin D3  and the  regulation of macrophage function.  Calcif. Tissue Int. 33:
     673-676.

Baraldi,  M.;  Zanoli,  P.;  Rossi, T.; Borella, P.; Caselgrandi, E.;  Petraglia, F.  (1985) Neuro-
     behavioral  and  neurochemical  abnormalities of  pre- and postnatally lead-exposed  rats:
     zinc,  copper and calcium status.  Neurobehav. Toxicol. Teratol. 7: 499-509.

Barlow,  K.  A.;  Beilin,  L.  J.  (1968)  Renal disease  in  primary gout.  Q.  J.  Med. 37: 79-98.

Barltrop, D.  (1966) The prevalence of  pica. Am. J. Dis. Child. 112: 116-123.

Barltrop,  D.;  Barrett,  A.  J.;  Dingle, J.  T.  (1971) Subcellular  distribution  of lead in the
     rat. J.  Lab. Clin.  Med.  77: 705-712.

Barrett,  J.;  Livesey, P.  J.  (1982)  The acetic acid component of  lead  acetate: its effect  on
     rat  weight and activity. Neurobehav.  Toxicol. Teratol. 4: 105-108.

Barrett,  J.;  Livesey, P. J. (1983) Lead induced alterations in maternal behavior  and offspring
     development in the rat.  Neurobehav.  Toxicol. Teratol. 5: 557-563.

Barrett,  J.;  Livesey, P.  J.  (1985)  Low  level lead effects on  activity under varying stress
     conditions  in the developing rat. Pharmacol. Biochem. Behav.  22: 107-118.

Barry,  P.  S.  I.  (1975)  A comparison of concentrations of  lead  in human tissues. Br. J.  Ind.
     Med. 32: 119-139.

Barthalmus,  G. T.;  Leander,  J.  D.;  McMillan, D. E.; Mushak, P.; Krigman,  M.  R. (1977) Chronic
     effects  of  lead on  schedule-controlled pigeon  behavior.  Toxicol.  Appl.  Pharmacol. 42:
     271-284.

Barton,  0.  C.;  Conrad,  M.  E.; Nuby, S.;  Harrison, L. (1978) Effects  of  iron on the  absorption
     and  retention of lead. J. Lab.  Clin.  Med. 92: 536-547.

Batuman,  V.; Maesaka, J. K.; Haddad, B.;  Tepper, E.; Landry, E.; Wedeen,  R.  P.  (1981)  The role
     of  lead  in gout nephropathy. N. Engl.  J. Med. 304: 520-523.
                                          12-294

-------
Batuman, V.; Landy,  E.;  Maesaka, J. K.; Wedeen,  R.  P.  (1983) Contribution  of  lead to hyper-
     tension with renal impairment. N.  Engl. J. Med. 309: 17-21.

Bauchinger,  M.;  Schmid,  E.  (1972) Chromosomenanalysen  in  Zellkulturen  des chinesischen Ham-
     sters  nach  Application  von   Bleiacetat  [Chromosome  analysis  in  Chinese  hamster  cell
     cultures after treatment with  lead acetate]. Mutat. Res. 14: 95-100.

Bauchinger,  M.  ;  Schmid,  E.;  Schmidt, D. (1972)  Chromosomenanalyse  bei  Verkehrspolizisten mit
     erhohter  Bleilast  [Chromosome  analysis  of policemen  with  increased  blood  lead level].
     Mutat.  Res. 16: 407-412.

Bauchinger,  M. ;  Schmid,  E.  ;  Einbrodt,  H.  J. ;  Dresp,  J.  (1976)  Chromosome  aberrations  in
     lymphocytes  after occupational  exposure  to  lead  and  cadmium.  Mutat. Res.  40: 57-62.

Bauchinger,  M.; Dresp, J.; Schmid,  E.; Englert,  N.; Krause,  Chr.  (1977)  Chromosome  analyses  of
     children after ecological lead exposure.  Mutat. Res.  56: 75-80.

Beattie, A.  D.; Moore, M. R.; Goldberg, A.; Finlayson, M.  J.  W.;  Graham, J.  F.; Mackie, E. M.;
     Main, J.  C.;  McLaren,  0. A.;  Murdoch,  K. M. ; Stewart,  G.  T.  (1975)  Role  of chronic  low-
     level  lead  exposure  in  the  aetiology of  mental   retardation.  Lancet 1(7907):  589-592.

Bedford,  J.  M.;  Calvin,  H.   I.  (1974) Changes  in -S-S- linked  structures  of  the  sperm  tail
     during  epididymal maturation, with comparative observations in  sub-mammalian  species.  J.
     Exp.  Zool.  187: 181-203.

Beek,  B.; Obe,  G.   (1974)  Effect  of  lead acetate on  human leukocyte  chromosomes jji vitro.
     Experientia  30: 1006-1007.

Beek,  B.; Obe,  G.  (1975) The  human leukocyte  test system:  VI.  the use of sister chromatid
     exchanges  as  possible   indicators  for mutagenic   activities.   Humangenetik 29:  127-134.

Beevers,  D.  G.;  Erskine,  E.; Robertson,  M.;  Beattie,  A.  D.;  Campbell, B. C.;  Goldberg, A.;
     Moore,  M.  R.;  Hawthorne, V.  M.  (1976) Blood-lead and  hypertension.  Lancet  2(7975):  1-3.

Beevers,  D.  G. ; Cruickshank, J. K.; Yeoman,  W. B.; Carter,  G.  F.; Goldberg, A.; Moore, M.  R.
     (1980)  Blood-lead  and   cadmium  in human  hypertension.  J.   Environ.  Pathol.  Toxicol.  4:
     251-260.

Bel knap,  E.  L.  (1936) Clinical  studies on lead  absorption  in  the  human:   III.  blood  pressure
     observations.  J.  Ind. Hyg.  Toxicol. 18: 380-390.

Bellinger, D.  C.; Needleman,  H.  L.  (1983)  Lead and the  relationship between maternal and  child
     intelligence.  J.  Pediatr.  (St. Louis) 102:  523-527.

Bellinger, D.  C.; Needleman, H.  L.; Leviton,  A.; Waternaux, C.;  Rabinowitz, M.  B.;  Nichols,  M.
     L.  (1984a)  Early  sensory-motor  development  and  prenatal  exposure to  lead.  Neurobehav.
     Toxicol.  Teratol. 6:  387-402.

Bellinger,  D.;  Needleman,  H. L.;  Bromfield,  R.;  Mintz,  M. (1984b) A followup study  of the
     academic  attainment  and classroom behavior of children with elevated dentine  lead levels.
     Biol. Trace Elem. Res.  6:  207-223.
                                           12-295

-------
Bellinger,  D.;  Leviton,  A.;   Waternaux,  C.;  Allred,  E.  (1985)  Methodological   issues  in
     modelling  the  relationship  between  low-level  lead  exposure  and  infant development:
     examples from  the  Boston  lead study.  In:  Bornschein,  R.  L.; Rabinowitz, M. B., eds. The
     second international  conference  on prospective studies of  lead;  April  1984; Cincinnati,
     OH. Environ. Res. 38: 119-129.

Benignus, V. A.; Otto, D. A.; Muller, K. E.;  Seiple, K. J. (1981) Effects of age and body lead
     burden  on   CNS  function in  young children:  II.  EEG spectra.  Electroencephalogr.  Clin.
     Neurophysiol. 52: 240-248.

Beritic,  T.  (1971)  Lead  concentration found  in  human blood  in association  with lead colic.
     Arch. Environ. Health 23:  289-291.

Berk, P. D.; Tschudy, D. P.; Shepley, L. A.;  Waggoner, J. G.;  Berlin, N. I. (1970) Hematologic
     and biochemical studies in a case of  lead poisoning. Am.  J. Med. 48: 137-144.

Betts, P. R.; Astley, R.; Raine, D. N. (1973) Lead intoxication  in children in Birmingham. Br
     Med. J. 1(5850): 402-406.

Bhalla,  A.  K.;   Amento,  E.  P.;   Clemens,  T.   L.;  Holick, M.  F.;  Krane,  S.  M.  (1983) Specific
     high-affinity  receptors for  1,25-dihydroxyvitamin  D3  in  human  peripheral  blood mono-
     nuclear cells: presence in monocytes and induction in T lymphocytes following activation
     J. Clin.  Endocrinol. Metab. 57: 1308-1310.

Biagini, G.;  Caudarella,  R.; Vangelista, A.  (1977) Renal morphological and functional modifi-
     cation in  chronic  lead poisoning.  In: Brown,  S.  S., ed.  Clinical chemistry and chemical
     toxicology  of metals. New York, NY: Elsevier/North-Holland  Biomedical Press; pp. 123-126.

Bjorklund,  H.;  Olson, L.; Seiger,  A.;  Hoffer,  B. (1980)  Chronic  lead and brain development:
     intraocular  brain   grafts  as  a  method   to  reveal  regional  and temporal effects  in the
     central nervous system. Environ. Res.  22: 224-236.

Blackfan, K.  D.  (1917)  Lead poisoning  in  children with especial reference to lead  as a cause
     of convulsions. Am. J. Med. Sci. 153:  877-887.

Blackman,  S.  S., Jr. (1936) Intranuclear  inclusion  bodies in the kidney  and  liver caused by
     lead poisoning. Bull. Johns Hopkins Hosp. 58: 384-403.

Blackman, S.  S., Jr.  (1937) The lesions of lead encephalitis  in children. Bull. Johns Hopkins
     Hosp. 61: 1-43.

Blakley,  B.  R.; Archer,  D.  L.   (1981)  The effect  of lead acetate  on  the  immune response in
     mice. Toxicol. Appl. Pharmacol. 61: 18-26.

Blakley,  B.  R.;  Archer,  D.  L.   (1982)  Mitogen stimulation of lymphocytes exposed to lead.
     Toxicol.  Appl. Pharmacol.  62: 183-189.

Blakley, B. R.;  Sisodia, C.  S.; Mukkur, T.  K.  (1980) The effect of methylmercury,  tetraethyl
     lead,  and  sodium   arsenite  on  the  humoral  immune  response   in mice.   Toxicol.  Appl.
     Pharmacol.  52: 245-254.

Blakley,  B.  R.; Archer,  D.  L.;  Osborne,  L.  (1982)  The effect  of  lead on  immune and viral
     interferon production. Can. J. Comp. Med. 46: 43-46.


                                          12-296

-------
Blanksma,  L.  A.; Sachs,  H.  K.; Murray,  E.  F.;  O'Connell, M.  J.  (1969)  Failure  of urinary
     6-anrinolevulinic acid (ALA) test to detect pediatric lead poisoning. Am. J. Clin. Pathol.
     52: 96.

Bloomer, J.  R.  (1980) Characterization of deficient  heme  synthase activity in protoporphyria
     with cultural skin fibroblasts. J. Clin. Invest. 65: 321-323.

Bluestone, R.; Waisman, J.; Klinenberg, J. R. (1977) The gouty kidney. Semin. Arthritis Rheum.
     7: 97-112.

Boeckx, R. L.; Posti, B.; Coodin, F. J. (1977) Gasoline sniffing  and  tetraethyl lead poisoning
     in children. Pediatrics 60: 140-145.

Bondy,  S. C.; Agrawal, A. K. (1980) The inhibition of cerebral high affinity receptor  sites  by
     lead and mercury compounds. Arch. Toxicol. 46: 249-256.

Bondy,  S. C.; Anderson, C.  L.; Harrington, M. E.; Prasad, K. N.  (1979a)  The effects  of organic
     and  inorganic   lead  and  mercury  on  neurotransmitter  high-affinity transport and release
     mechanisms.  Environ. Res. 19:  102-111.

Bondy,  S. C.; Harrington, M. E.; Anderson, C. L.; Prasad, K. N.  (1979b)  The effect of  low con-
     centrations  of  an organic lead compound on the transport  and release of  putative  neuro-
     transmitters. Toxicol. Lett. 3: 35-41.

Booze,  R.  M.; Mactutus, C. F.; Annau, Z.; Tilson, H.  A. (1983) Neonatal  triethyl  lead  neuro-
     toxicity in rat pups:  initial behavioral  observations and quantification.  Neurobehav.
     Toxicol. Teratol.  5: 367-375.

Border,  E.  A.;  Cantrell, A. C. ; Kilroe-Smith,  T. A.  (1976) The  HI vitro effect of  zinc  on the
     inhibition  of  human 6-aminolevulinic  acid dehydratase  by lead.  Br. J.  Ind.   Med.  33:
     85-87.

Bordo,  B. M.; Filippini,  G.; Massetto,  N.; Musicco,  M.; Boeri,  R. (1982a) Electrophysiological
     study  of subjects occupationally exposed  to lead and with  low  levels of lead  poisoning.
     Scand.  J. Work  Environ. Health 8  (suppl. 1): 142-147.

Bordo,  B.;  Massetto,  N.;  Musicco, M.;  Filippini,  G. ; Boeri,   R. (1982b) Electrophysiologic
     changes in  workers with "low"  blood  lead  levels.  Am. J.  Ind. Med.  3:  23-32.

Bornschein,  R.  L.;   Rabinowitz, M.  B., eds.(1985) The second international conference on pros-
     pective studies of lead;  April 1984; Cincinnati,  OH.  Environ. Res.  38(1).

Bornschein,  R.;  Pearson,  D.; Reiter,  L.  (1980)  Behavioral  effects of  moderate lead exposure in
     children and animal models: part 2, animal studies.  CRC Crit.  Rev. Toxicol.  8:  101-152.

Borova", J.; Ponka,   P.; Neuwirt,  J. (1973)  Study of  intracellular iron distribution  in rabbit
     reticulocytes   with  normal and  inhibited  heme  synthesis.   Biochim.  Biophys.  Acta 320:
     143-156.

Boscolo,  P.; Galli,  G.;  lannaccone,  A.;  Martino, F.; Porcelli,   G.; Troncone,  L. (1981)  Plasma
      renin  activity and  urinary kallikrein excretion  in  lead-exposed workers  as  related to
     hypertension and nephropathy.  Life Sci. 28: 175-184.
                                           12-297

-------
Bouldin, T.  W.;  Mushak,  P.;  O'Tuama,  L.  A.;  Kn'gman, M. R.  (1975)  Blood-brain barrier dys-
     function  in  acute  lead encephalopathy:  a  reappraisal.  Environ.  Health  Perspect.  12-
     81-88.

Bouldin, T.  W.;  Meighan,  M.  E. ; Gaynor,  J.  J. ;  Goines, N.  0.;  Mushak, P.;  Krigman,  M.  R.
     (1985)  Differential  vulnerability of  mixed and cutaneous nerves  in lead nephropathy J.
     Neuropathol.  Exp. Neurol. 44: 384-396.

Bouley, G.;  Dubreuil, A.;  Arsac, F.;  Boudene,  C.  (1977)   Effet  du  plomb microparticulaire,
     introduit dans 1'appareil respiratoire, sur la sensibility de la souris i 1'infection par
     aerosol  de  Pasteurella multocida   [Effect of  microparticulate  lead,  introduced through
     respiratory apparatus, on  the  resistance of mice to infection by aerosolized Pasteurella
     multocida].   C. R. Hebd.  Seances Acad. Sci. Ser. D 285:  1553-1556.                     —

Bowie,  E.  A.; Simmonds,  H.  A.;  North, J.  D.  K.  (1967)  Allopurinol  in treatment of patients
     with gout and chronic renal  failure.  N. Z. Med. J. 66: 606-611.

Boyland, E.;  Dukes, C.  E.;  Grover, P. L.; Mitchley,  B.  C.  V. (1962)  The  induction of renal
     tumours by feeding lead acetate to rats.  Br. J. Cancer 16: 283-288.

Bradley, J.  E.;  Baumgartner,  R. J.  (1958) Subsequent mental  development  of children with lead
     encephalopathy,  as  related  to  type  of  treatment.  J.  Pediatr.  (St.  Louis) 53: 311-315.

Bradley, J.  E.;  Powell,  A. E.; Niermann,  W.;  McGrady, K. R.; Kaplan,  E. (1956) The incidence
     of abnormal blood levels of lead  in a metropolitan  pediatric clinic: with  observation on
     the value  of coproporphyrinuria  as  a screening  test.  J. Pediatr.  (St.  Louis) 49: 1-6.

Brashear,  C.  W.;   Kopp,   V.  J.; Krigman, M.  R.   (1978) Effect  of   lead  on  the  developing
     peripheral nervous system. J. Neuropathol. Exp. Neurol.  37: 414-425.

Braunstein,  G.  D.;  Dahlgren,  J. ;  Loriaux,  D.  L.  (1978)  Mypogonadism  in  chronically lead-
     poisoned men.  Infertility 1: 33-51.

Brennan, M.  J. W.;  Cantrill,  R. C.  (1979) 6-Aminolaevulinic acid is a potent  agonist for GABA
     autoreceptors. Nature (London)  280: 514-515.

Brieger,  H.; Rieders, F.  (1959) Chronic  lead and  mercury  poisoning:  contemporary  views  on
     ancient occupational diseases.  J.  Chronic Dis. 9:  177-184.

Briney, W.  G.; Ogden, D.; Bartholomew,  B.; Smyth,  C. J. (1975) The influence of  allopurinol on
     renal function in gout. Arthritis  Rheum.  (Suppl.) 18: 877-881.

Broman, S.  H.; Nichols, P. L.; Kennedy, W.  A.  (1975) Preschool IQ: prenatal and  early develop-
     mental correlates. Hillsdale, NJ:  Lawrence Erlbaum Associates, pp.  1-16.

Brown,  D.  R.  (1975) Neonatal  lead exposure in  the rat:   decreased learning  as  a function of
     age and blood lead concentrations. Toxicol. Appl.  Pharmacol. 32:  628-637.

Brown, J.; Mallory, G. K.  (1950)  Renal  changes in  gout. N. Engl. J. Med.  243:  325-329.

Brown,  S.;  Dragann,  N.;  Vogel, W. H. (1971) Effects of lead acetate on  learning and memory in
     rats.  Arch.  Environ. Health  22: 370-372.
                                          12-298

-------
Bruce, W. R.;  Heddle,  J.  A.  (1979) The  mutagenic  activity of 61  agents  as determined by the
     micronucleus,  Salmonella,   and  sperm  abnormality  assays.  Can.   J.   Genet.  Cytol.  21:
     319-334.

Bryce-Smith, D.;  Deshpande,  R.  R.;  Hughes, J.; Waldron,  H.  A.  (1977) Lead and cadmium levels
     in stillbirths. Lancet 1(8022): 1159.

Buc, H. A.;  Kaplan, J.  C.  (1978) Red-cell pyrimidine 5'-nucleotidase and lead poisoning. Clin.
     Chim. Acta 87: 49-55.

Buchet,  J.-P.;  Roels,  H.;  Bernard, A.;  Lauwerys,  R. (1980) Assessment  of renal function of
     workers exposed to  inorganic lead,  cadmium or mercury vapor. J. Occup. Med.  22:  741-750.

Buchet, J.-P.;  Roels, H.; Hubermont, G.;  Lauwerys, R.  (1976) Effect of  lead on  some  parameters
     of the heme biosynthetic pathway  in  rat tissues  i_n vivo. Toxicology 6: 21-34.

Buchthal, F.;  Behse,  F.  (1979)  Electrophysiology and  nerve biopsy in men  exposed to lead. Br.
     J. Ind. Med.  36: 135-147.

Buchthal, F.;  Behse,  F.  (1981)  Nerve  conduction  and nerve biopsy in men  exposed to lead.  In:
     Lynam, D.  R.;  Piantanida,  L. G.;  Cole, J.  F., eds. Environmental lead: proceedings of  the
     second  international symposium on lead research;  December  1978; Cincinnati,  OH.  New York,
     NY:  Academic Press;  pp. 69-94.  (Coulston, F.;  Korte,  F.,  eds.  Ecotoxicology and environ-
     mental quality series).

Buelke-Sam,  J.; Kimmel,  C.  A.;  Adams, J.,  eds. (1985) Design  considerations  in  screening  for
     behavioral   teratogens:   results  of  the  collaborative   behavioral teratology study.
     Neurobehav.  Toxicol. Teratol.  7:  537-789.

Bull,  R.  J.  (1977) Effects of trace metals  and their  derivatives  on the  control  of brain
     energy  metabolism.  In:  Lee, S.  D.,  ed.  Biochemical  effects  of environmental pollutants.
     Ann  Arbor, MI: Ann Arbor Science; pp. 425-440.

Bull,  R.  J.  (1980) Lead  and energy metabolism. In:   Singhal,  P.  L.;  Thomas,  J.  A.,  eds.  Lead
     toxicity.  Baltimore, MD: Urban and  Schwarzenberg,  Inc.; pp.  119-168.

Bull,  R.  J.  (1983) Delayed metabolic maturation of  the  cerebral cortex of rat pups derived
     from lead-treated dams. J.  Toxicol.  Environ.  Health  11: 211-225.

Bull,  R.  J.;  Stanaszek,  P. M.; O'Neill, J.  J.;  Lutkenhoff,  S.  D.  (1975) Specificity of  the
     effects of lead on brain energy  metabolism for  substrates  donating a cytoplasmic reducing
     equivalent.  Environ. Health Perspect.  12:  89-95.

Bull,  R.  J.; Lutkenhoff, S.  D.; McCarty, G.  E.;  Miller,  R. G.  (1979)  Delays in the postnatal
      increase  of  cerebral  cytochrome concentrations  in  lead-exposed  rats.  Neuropharmacology
      18:  83-92.

Bull,  R.  J.; McCauley, P.  T.;  Taylor, D. H.;  Croften, K.  M.  (1983) The effects of  lead on the
      developing central  nervous system of the rat.  Neurotoxicology 4:  1-18.

Bulsma,   J.   B.; De  France,  H.   F.  (1976) Cytogenetic  investigations   in  volunteers  ingesting
      inorganic lead.  Int. Arch. Occup. Environ. Health 38: 145-148.
                                           12-299

-------
Burchfiel, J.  L.;  Duffy,  F.  H.; Bartels, P. H.; Needleman, H. L. (1980) The combined discrim-
     inating  power of  quantitative  electroencephalography  and neuropsychologic  measures in
     evaluating  central  nervous system effects  of  lead at low  levels.  In:  Needleman,  H. L.,
     ed.  Low level lead exposure: the clinical  implications of current research. New York, NY:
     Raven Press; pp.  75-89.

Bushnell,  P.  J.  (1978) Behavioral  toxicology  of lead  in  the  infant Rhesus monkey [disserta-
     tion].  Madison,   WI:   University  of  Wisconsin-Madison.   Available  from:   University
     Microfilms, Ann Arbor, MI; publication no. 78-15,037.

Bushnell,  P.  J. ;  Levin,  E.  D.  (1983)  Effects of  zinc deficiency  on  lead toxicity in  rats.
     Neurobehav.  Toxicol.  Teratol.  5: 283-288.

Bushnell, P.  J.; Bowman, R.  E.; Allen, J.  R.; Marlar, R. J. (1977) Scotopic vision deficits In
     young monkeys exposed to  lead. Science (Washington, DC) 196: 333-335.

Bushnell,  P. J.;  Bowman,  R.  E. (1979a) Reversal learning  deficits in young monkeys exposed to
     lead. Pharmacol.  Biochem. Behav. 10:  733-742.

Bushnell,  P.  J.;  Bowman,  R.   E. (1979b)  Persistence of  impaired reversal  learning in  young
     monkeys exposed to  low  levels of dietary  lead. J.  Toxicol. Environ. Health 5: 1015-1023.

Bushnell, P.  J.; Bowman, R.  E. (1979c) Effects of chronic  lead ingestion on social development
     in infant Rhesus monkeys. Neurobehav.  Toxicol.  1:  207-219.

Butrimovitz, G.  P.; Sharlip,  I.; Lo, R. (1983) Extremely low seminal lead concentrations and
     male fertility. Clin. Chim. Acta 135:  229-231.

Byers, R.  K.;  Lord,  E.  E. (1943) Late effects of lead  poisoning on mental development. Am. J
     Dis. Child.  66: 471-494.

Cadman, H. C. (1905) Lead as an abortifacient [letter].  Br. Med. J. 1: 653.

Caldwell,  B.  M.; Bradley, R.  H. (1979)  Home observation  for  measurement  of the environment.
     Little Rock, AR:  University of Arkansas at Little  Rock.

Calvin, H. I.;  Bedford,  J.  M. (1971) Formation of  disulphide bonds in the nucleus and acces-
     sory  structures of mammalian  spermatozoa during maturation in the epididymis. J. Reprod
     Fertil.  Suppl. 13:  65-75.

Campara,  P.; D'Andrea,  F.; Micciolo, R.; Savonitto,  C.;  Tansella, M.; Zimmermann-Tansella, Ch.
     (1984)  Psychological  performance  of  workers  with   blood'lead  concentration  below the
     current threshold limit value. Int. Arch. Occup. Environ. Health 53: 233-246.

Campbell,  B.  A.;  Lytle,   L.  D.;  Fibiger,  H.  C.   (1969)  Ontogeny of adrenergic  arousal and
     cholinergic  inhibitory  mechanisms  in the rat. Science  (Washington, DC)  166: 635-637.

Campbell,  B. C.;  Beattie,  A.  D.; Moore, M.  R.; Goldberg, A.; Reid, A. G.  (1977) Renal insuf-
     ficiency associated with excessive lead exposure.  Br. Med. J. 1(6059): 482-485.

Campbell,  B. C.;  Moore,  M.  R.; Goldberg, A.; Hernandez, L. A.; Dick, W. C. (1978) Subclinical
     lead exposure: a possible cause of gout.  Br. Med.  J.   2(6149): 1403.
                                          12-300

-------
Campbell, B. C.;  Beattie,  A.  D.; Elliott,  H.  L. ;  Goldberg, A.; Moore, M. R. ; Beevers, D. G.;
     Tree, M.  (1979)  Occupational  lead exposure and  renin  release.  Arch. Environ. Health 34:
     439-443.

Campbell, J. B. ;  Woolley,  D.  E.; Vijakan,  V.  K. ;  Overmann, S. R. (1982) Morphometric effects
     of postnatal  lead  exposure on hippocampal development of the 15-day-old rat. Dev. Brain
     Res. 3: 595-612.

Cannon,  P.  J. ;  Stason,  W.  B.;  Demartini,  F.  E. ;  Sommers,  S.  C. ;  Laragh, J. H.   (1966) Hyper-
     uricemia in primary and  renal hypertension. N. Engl. J. Med.  275: 457-464.

Cantarow,  A.;   Trumper,  M.  (1944)  Lead  poisoning.   Baltimore,  MD:  Williams  and Wilkins Co.

Capel,  I.  D.;  Pinnock,  M.  H.;  Dorrell, H.  M.; Williams, D.  C.;  Grant,  E.  C.  G. (1981) Com-
     parison of concentrations  of some trace, bulk, and  toxic  metals  in the  hair  of normal and
     dyslexic children. Clin. Chem. (Winston-Salem, NC)  27:  879-881.

Capobianco,  S.; Hamilton, L. W.  (1976)  Effects of interruption  of limbic  system pathways  on
     different  measures of activity.  Physiol. Behav.  17:  65-72.

Carpenter,  S.  J.  (1982)  Enhanced teratogenicity of  orally administered  lead in  hamsters fed
     diets  deficient  in calcium or iron. Toxicology 24:  259-271.

Carpenter,  S.  J.; Perm, V. H.  (1977) Embryopathic effects  of lead in the  hamster:  a  morpho-
     logic  analysis.  Lab.  Invest. 37:  369-385.

Carroll,  K.  G. ;  Spinelli,  F.  R. ; Goyer,  R.  A.  (1970)  Electron  probe microanalyser localization
     of  lead in kidney tissue of poisoned  rats. Nature (London) 227:  1056.

Castellino,  N.; Aloj, S.  (1969)  Intracellular  distribution of lead in the liver and  kidney  of
     the  rat.  Br.  J.  Ind.  Med.  26: 139-143.

Casto,  B.  C.;   Meyers,  J.; DiPaolo,  J.  A.  (1979)  Enhancement  of  viral  transformation for
     evaluation of the  carcinogenic  or mutagenic  potential of inorganic metal  salts.  Cancer
     Res.  39:  193-198.

Castranova,  V.; Bowman, L. ;  Reasor,  M.  J. ; Miles,  P. R. (1980) Effects of heavy metal  ions  on
     selected   oxidative  metabolic  processes  in  rat  alveolar  macrophages.  Toxicol.  Appl.
     Pharmacol.  53:  14-23.

Catton,  M.  J.; Harrison,  M.  J. G.;  Fullerton, P.  M.;  Kazantzis, G.  (1970)  Subclinical neuro-
     pathy in  lead workers.  Br. Med.  J.  2(5670):  80-82.

Cerottini,  J.  C.; Brunner,  K.  T.  (1974) Cell-mediated  cytotoxicity,  allograft  rejection, and
     tumor immunity.  Adv.  Immunol.  18:  67-132.

Chang,  L. W. ; Wade,  P.  R. ;   Lee, G.  W.  (1981)  An ultrastructural reevaluation of lead-induced
     pathology in the kidney. Environ.  Res. 26:  136-151,

Charcot,  J.-M.   (1874)  Lecons  cliniques  sur les  maladies  des vieillards  et  les maladies
     chroniques  [Clinical  studies of geriatric  and chronic  diseases]. 2nd rev.  ed.  Paris,
      France: Adrien Delahaye.
                                           12-301

-------
Charcot; Gombault.  (1881)  Note relative a 1'etude anatomique de la nephrite saturnine expeYi-
     mentale  [Note  on the  anatomical  study  of  experimental lead  nephritis].  Arch.  Physio!
     Norm.  Pathol. 13: 126-154.

Chesney,  R.   W.;  Rosen,  J.  F.;  DeLuca,  H.   F.  (1983)  Disorders  of  calcium metabolism  in
     children.  In:   Chiumello,   G.;   Sperling,   M.,  eds..  Recent   progress   in  pediatric
     endocrinology.  New York, NY:  Raven Press; pp. 5-24.

Cheung,  W.   Y.  (1980)  Calmodulin  plays  a  pivotal  role   in  cellular  regulation.   Science
     (Washington,  DC) 207:  19-27.

Chisolm, J.  J., Jr.  (1962) Aminoaciduria as  a manifestation of renal  tubular  injury in lead
     intoxication and a  comparison  with patterns of aminoaciduria  seen in other diseases.  J
     Pediatr. (St. Louis) 60: 1-17.

Chisolm, J.  J., Jr.  (1965) Chronic  lead  intoxication  in  children.  Dev. Med.  Child Neurol.  7-
     529-536.

Chisolm, J.  J., Jr.  (1968) The use  of  chelating  agents in the treatment of acute and chronic
     lead intoxication in childhood. J.  Pediatr.  (St. Louis) 73: 1-38.

Chisolm, J.  J., Jr.  (1981) Dose-effect relationships  for  lead  in young children: evidence in
     children for interactions among lead, zinc, and iron. In: Lynam, D. R.; Piantanida, L.  G;
     Cole,  J.  F., eds.  Environmental lead:  proceedings of  the  second international symposium
     on  environmental  lead research; December 1978;  Cincinnati,  OH. New  York,  NY:  Academic
     Press;  pp.  1-7.  (Coulston,  F.; Korte, F., eds.  Ecotoxicology  and environmental quality
     series).

Chisolm, J.  J., Jr.; Barltrop, D.  (1979) Recognition and management of children with increased
     lead absorption. Arch. Dis.  Child.  54:  249-262.

Chisolm, J.  J., Jr.;  Brown, D. H. (1979) Micromethpd for zinc protoporphyrin in erythrocytes:
     including new  data on  the  absorptivity  of  zinc protoporphyrin  and  new observations  in
     neonates and sickle cell disease.  Biochem. Med.  22: 214-237.

Chisolm, J.  J., Jr.;  Harrison, H. E. (1956)  The  exposure of children to lead.  Pediatrics 18-
     943-958.

Chisolm, J.  J., Jr.;  Harrison, H. C.;  Eberlein, W.   R.; Harrison, H.  E. (1955) Amino-aciduria,
     hypophosphatemia, and  rickets  in  lead  poisoning:  study of a case. Am. J. Dis. Child. 89-
     159-168.

Chisolm, J.  J., Jr.; Mellits, E.  D.; Barrett,  M.  B.   (1976) Interrelationships among blood lead
     concentration,  quantitative  daily  ALA-U  and  urinary lead  output following calcium EDTA.
     In: Nordberg,  G.  F.;  ed. Proceedings  of  third  meeting of the  subcommittee  on the toxi-
     cology  of  metals  under  the  Permanent  Commission  and   International  Association  on
     Occupational  Health;  November   1974; Tokyo,  Japan. Amsterdam,  The Netherlands:  Elsevier
     Publishing Co.; pp.  416-433.

Choie, D. D.;  Richter,  G.  W. (1972a) Cell proliferation in rat kidney induced by lead acetate
     and effects of uninephrectomy on the proliferation. Am. J.  Pathol. 66: 265-275.
                                          12-302

-------
Choie,  D.  D.;  Richter,  G.  W.  (1972b)  Cell  proliferation  in rat  kidneys  after  prolonged
     treatment with lead. Am. J. Pathol. 68: 359-370.

Choie, D.  D.;  Richter,  G. W.  (1974a)  Cell  proliferation in mouse  kidney  induced by lead. I:
     Synthesis of deoxyribonucleic acid. Lab. Invest. 30: 647-651.

Choie, D.  D.,  Richter,  G. W.  (1974b)  Cell  proliferation in mouse  kidney  induced by lead:  II.
     synthesis of ribonucleic  acid and protein. Lab. Invest. 30: 652-656.

Choie, 0.  0.; Richter,  G.  W.;  Young,  L.  B.  (1975) Biogenesis  of intranuclear lead-protein
     inclusions in mouse  kidney. Beitr. Pathol. 155: 197-203.

Chow,  C.  P.;  Cornish,  H. H.  (1978) Effects  of  lead  on  the  induction of  hepatic  microsomal
     enzymes  by  phenobarbital  and 3,4-benzpyrene.  Toxicol.   Appl.  Pharmacol.  43: 219-228.

Chowdhury, A.  R.;  Dewan, A.;  Gandhi,  D.  N. (1984)  Toxic  effect  of lead on the testes  of rat.
     Biomed. Biochim. Acta 43:  95-100.

Chrus"ciel, H.  (1975) Wplyw toksycznych  czynnikdw  s>odowiska pracy na powstawanie leukoplakii  u
     hutnikdw  cynku  i olowiu [The  effect  of toxic environmental products on the development of
      leucoplakia  in  workers in  zinc and  lead  processing plants].  Czas.  Stomatol.  28: 103-110.

CihaX  A.; Seifertovd,  M.   (1976)  Simulated DNA  synthesis in livers  and  kidneys  induced to
     proliferate  associated with unchanged thymidine  and thymidylate kinase activities.  Chem.
     Biol. Interact. 13:  141-149.

Clark,  A.  R.  L.  (1977)  Placental  transfer of lead  and its effects on  the newborn.  Postgrad.
     Med.  J.  53: 674-678.

Clark,  S.  A.;  Stumpf,  W.  E.; Sar, M.  (1981) Effect  of  1,25-dihydroxyvitamin  03  on  insulin
      secretion. Diabetes 30:  382-386.

Clarkson,  T.  W.;  Kench,  J.  E. (1956) Urinary excretion of amino acids by men absorbing heavy
      metals.  Biochem. J.  62:  361-372.

Cohen,  G.  J.;  Ahrens, W.  E.  (1959) Chronic lead poisoning: a review of seven years'  experience
      at  the  Children's  Hospital, District of  Columbia. J. Pediatr. (St.  Louis) 54:  271-284.

Cohen,  J.; Cohen,  P.   (1975)  Applied multiple  regressional/correlation  analysis  for  the be-
      havioral  sciences.  Hillsdale, NJ: Lawrence Erlbaum Associates; pp. 123-167.

Cohen,  D.  J.;  Johnson,  W.  T.; Caparulo,  B. K.  (1976) Pica and elevated blood lead  level in
      autistic and atypical  children. Am.  J. Dis.  Child. 130: 47-48.

Cole,  L. J.;  Bachhuber,  L.  J. (1915) The  effect of lead  on the germ cells of the male  rabbit
      and fowl as  indicated by their progeny. Proc.  Soc. Exp. Biol. Med. 12: 24-29.

 Cole,  R.;  Cole,  J.  (1976)  Correlations  between disturbed haem  synthesis and fetal malforma-
      tion. Lancet 2(7986):  640.

 Colle, A.; Grimaud, J.  A.;  Boucherat, M.; Manuel,  Y.   (1980)  Lead poisoning  in monkeys:  func-
      tional  and histopathological alterations of the kidneys. Toxicology  18:  145-158.
                                           12-303

-------
Collins, M.  F.;  Hrdina,  P.  D. ;  Whittle,  E.;  Singhal,  R.  L.  (1984)  The  effects of low-level
     lead exposure in developing rats: changes in circadian locomotor activity and hippocampal
     noradrenaline turnover.  Can. J. Physiol. Pharmacol. 62:  430-435.

Columbano,  A.; Ledda,  G.  M. ;  Sirigu, P.;  Perra,  T. ;  Pani, P. (1983) Liver cell proliferation
     induced by a single dose of lead nitrate. Am. J.  Pathol. 110: 83-88.

Conradi, S.;  Ronnevi,  L.-O.;  Vesterberg,  0.  (1976)  Abnormal tissue distribution  of  lead in
     amyotrophic lateral sclerosis.  J. Neurol. Sci.  29:  259-265.

Conradi, S.;  Ronnevi,  L.-O.;  Stibler,  H.   (1978a)  Serum protein binding of  lead  i_n vitro in
     amyotrophic lateral sclerosis patients and controls. J.  Neurol. Sci.  37: 95-105.

Conradi, S.;  Ronnevi,  L.-O.;  Vesterberg,  0.  (1978b)  Lead  concentration in skeletal muscle in
     amyotrophic  lateral   sclerosis  patients and  control  subjects.  J.   Neurol.  Neurosurg
     Psychiatry 41: 1001-1004.

Conradi, S.;  Ronnevi,  L.-O.;  Nise,  G.; Vesterberg, 0.  (1980) Abnormal distribution of lead in
     amyotrophic  lateral   sclerosis:   reestimation  of  lead  in   the  cerebrospinal  fluid.  J
     Neurol. Sci. 48: 413-418.

Cook, J.  A.; Marconi,  E.  A.; Di  Luzio,   N.  R.  (1974)  Lead,  cadmium,  endotoxin interaction:
     effect on mortality and hepatic function. Toxicol.  Appl. Pharmacol. 28: 292-302.

Cook, J.  A.; Hoffman,  E.  0.; Di  Luzio,   N.  R.  (1975)  Influence of lead  and  cadmium on the
     susceptibility of  rats  to bacterial  challenge.  Proc. Soc.  Exp.  Biol.  Med. 150: 741-747.

Cooley,  W.  W.;   Lohnes, P.  R. (1971) Multivariate  data analysis. New  York,  NY:  John  Wiley &
     Sons,  Inc.; pp.  3-28.

Cooper,  W.  C. (1976)  Cancer  mortality patterns  in the lead  industry.  Ann.  N.  Y.  Acad. Sci
     271:  250-259.

Cooper,  W.  C. (1981)  Mortality  in  employees of lead  production facilities  and lead battery
     plants,  1971-1975. In:  Lynam,  D. R.;  Piantanida,  L.  G. ; Cole, J.  F., eds. Environmental
     lead:  proceedings  of the second international symposium on environmental  lead research;
     December 1978;  Cincinnati,  OH. New York, NY: Academic Press; pp. 111-143.  (Coulston, F.;
     Korte, F.,  eds.  Ecotoxicology  and environmental  quality  series).

Cooper,  W.  C. (1985) Mortality among employees of lead  battery plants and lead-producing plants
     1947-1980.   Scand. J. Work Environ. Health 11: 331-345.

Cooper,  W.  C.;  Gaffey, W.  R. (1975) Mortality  of  lead workers. In:   Cole,  J.  F., ed.   Pro-
     ceedings of  the  1974 conference  on   standards  of occupational lead  exposure; February
     1974;  Washington, DC. J.  Occup. Med.  17: 100-107.

Cooper,  G.  P.; Manalis, R. S.  (1974) Effects of polyvalent cations on synaptic transmission in
     frog  neuromuscular  junction and  frog sympathetic  ganglion. In:  Xintaras,  C.; Johnson,
     B.  L.; de Groot, I.,  eds. Behavioral toxicology:  early detection of occupational hazards.
     Cincinnati,  OH:  U.   S.  Department of  Health,  Education,  and Welfare,  National Institute
     for Occupational  Safety  and  Health;   pp.  267-276.  DHEW  (NIOSH)  publication no.  74-126.
     Available from:  NTIS, Springfield, VA; PB-259322.
                                          12-304

-------
Cooper, G.  P.;  Steinberg, 0.  (1977)  Effects  of cadmium and  lead  on adrenergic neuromuscular
     transmission in the rabbit. Am. J. Physio!. 232: C128-C131.

Cooper, W.  C.;  Tabershaw,  I.  R.; Nelson,  K.  W.  (1973) Laboratory studies  of workers in lead
     smelting and refining.  In:  Barth, D.; Berlin, A.; Engel, R.; Recht, P.; Smeets, J., eds.
     Environmental health aspects of lead: proceedings, international symposium; October 1972;
     Amsterdam,  The  Netherlands.   Luxembourg:  Commission  of the  European  Communities;  pp.
     517-530.

Cooper, R.  A.;  Arner,  E.  C.;  Wiley,  J.   S.;  Shattil, S.  J.  (1975)  Modification  of red cell
     membrane  structure by  cholesterol-rich  lipid dispersions: a model  for the primary spur
     cell  defect. J. Clin. Invest.  55: 115-126.

Cooper, G.  P.;  Fox, D. A.;  Howell,  W.  E.; Laurie,  R.  D.;  Tsang,  W.; Lewkowski, J.  P.  (1980)
     Visual  evoked  responses in rats exposed  to  heavy metals.  In:  Merigan,  W.  H.;  Weiss, B.,
     eds.  Neurotoxicity of the  visual system.  New  York, NY:  Raven  Press;  pp.  203-218.

Cooper, G.  P.;  Suszkiw, J. B.; Manalis,  R. S.  (1984)  Heavy  metals:  effects on  synaptic  trans-
     mission. Neurotoxicology  5: 247-266.

Coro  Antich, R. M.;  Amoedo  Mon,  M. (1980) Effectos teratogenicos del plomo  [Teratogenic ef-
     fects  of lead].  Rev.  CENIC Cienc. Biol.  11:  115-128.

Corsi,  G.;  Bartolucci,  G.  B. ; Fardin,  P.;  Negrin,  P.;  Manzoni,  S.  (1984)  Biochemical and
     electrophysiological  study of subjects with  a history  of past  lead exposure.  Am.  J.  Ind.
     Med.  6:  281-290.

Cory-Slechta,  D.  A.; Thompson, T.  (1979) Behavioral toxicity of  chronic postweaning lead ex-
     posure in  the  rat. Toxicol. Appl. Pharmacol.  47:  151-159.

Cory-Slechta,  0.  A.;  Garman,  R.  H.; Seidman,  D.  (1980)  Lead-induced crop  dysfunction  in the
     pigeon.  Toxicol.  Appl.  Pharmacol. 52: 462-467.

Cory-Slechta, D.  A.;  Bissen, S.  T. ; Young, A.  M.;  Thompson,  T.  (1981) Chronic postweaning lead
     exposure and response duration performance.  Toxicol.  Appl.  Pharmacol.  60:  78-84.

Cory-Slechta,  D.  A.;  Weiss, B. ;  Cox, C.  (1983)  Delayed  behavioral  toxicity of lead with  in-
     creasing exposure concentration.  Toxicol.  Appl. Pharmacol.  71:  342-352.

Cory-Slechta,  D.  A.;  Weiss, B.;  Cox, C.  (1985)  Performance and exposure  indices  of rats  ex-
     posed  to low concentrations of lead. Toxicol. Appl.  Pharmacol.  78:  291-299.

Coss,  R.  G.; Glohus,  A.  (1978) Spine stems on tectal  interneurons in jewel fish are shortened
     by social  stimulation.  Science (Washington,  DC) 200:  787-790.

Costa, M.  (1980) Metal carcinogenesis  testing: principles  and  in vitro methods.  Clifton, NJ:
      Humana Press,  Inc.

Costa, L.  G.;  Fox, D. A. (1983) A selective decrease of cholinergic muscarinic  receptors  in
      the  visual  cortex of adult rats  following developmental  lead  exposure.  Brain Res. 276:
      259-266.
                                           12-305

-------
Costa,  M.;  Cantoni, 0.;  de Mars,  M.;  Swartzendruber,  D.  E.  (1982)  Toxic metals produce an
     S-phase-specific  cell  cycle block.  Res.  Commun.  Chem.  Pathol.  Pharmacol.  38:  405-419.

Cowan,  L. D.;  Leviton, A. (1980) Epidemiologic considerations in the  study of the sequelae of
     low  level  lead exposure.  In: Needleman, H. L., ed. Low level lead exposure: the clinical
     implications of current research. New York, NY: Raven Press; pp.  91-119.

Cramer,  K.;  Dahlberg,  L.  (1966) Incidence  of hypertension among  lead workers:  a follow-up
     study based on regular control over 20 years. Br. J. Ind.  Med. 23: 101-104.

Cramer,  K.;  Goyer,  R.  A.;  Jagenburg,  R.;  Wilson, M.  H.  (1974)  Renal  ultrastructure, renal
     function, and  parameters  of lead toxicity in  workers  with different periods of lead ex-
     posure.  Br. J.  Ind. Med.  31: 113-127.

Crofton,  K.  M.;  Taylor, D.  H.; Bull, R. J.; Sivulka, D. J.; Lutkenhoff, S. D. (1980) Develop-
     mental  delays  in  exploration  and locomotor  activity  in male  rats  exposed to low level
     lead. Life Sci. 26: 823-831.

Cullen,  M.  R.;  Kayne,   R. D.;  Robins,  J.  M.  (1984) Endocrine  and reproductive dysfunction in
     men  associated with occupational  inorganic lead intoxication.  Arch.  Environ.  Health 39-
     431-440.

Cumings,  J.  N.  (1959)  Heavy metals and the  brain.  Part 3: lead. Springfield, IL: Thomas; no
     93-155.

Cutler, M. G.  (1977)  Effects  of exposure to lead on social behaviour  in the  laboratory mouse
     Psychopharmacology 52:  279-282.

Czech,  D. A.;  Hoium,  E. (1984) Some  aspects  of feeding and locomotor activity  in adult rats
     exposed to tetraethyl lead. Neurobehav.  Toxicol. Teratol.  6: 357-361.

Dagg,  J.  H.;   Goldberg,  A.;   Lochhead,  A.;  Smith,  J.  A.  (1965)  The  relationship  of  lead
     poisoning to acute intermittent porphyria. Q. J. Med. 34:  163-175.

Dahlgren, J.  (1978) Abdominal  pain in lead workers. Arch. Environ. Health 33: 156-159.

Dalpra",  L.;  Tibiletti, M.G.;  Nocera,  G.;  Giulotto, P.; Auriti,  L.;  Carnelli,  V.; Simoni, G.
     (1983)  SCE  analysis in children  exposed  to  lead emission  from  a smelting plant. Mutat
     Res. 120:  249-256.

Dam'elsson,   B.  R.  G.;  Dencker,  L.;  Lindgren,  A.   (1983)  Transplacental  movement of inorganic
     lead in early and  late gestation in the mouse.  Arch. Toxicol. 54: 97-107.

Danilovid, V.  (1958)  Chronic  nephritis due to  ingestion of lead-contaminated flour. Br. Med
     J. 1(5061): 27-28.

Danjoy,  D'L.  (1864)  De  1'albuminurie dans  Tencephalopathie  et  Tamaurose  saturnines  [On
     albuminuria in encephalopathy and lead amaurosis]. Arch. Gen. Med. 1: 402-423.

David,  0.;  Clark,  J.;  Voeller,  K.  (1972) Lead  and  hyperactivity.  Lancet 2(7783):  900-903.

David,  0.  J.;  Hoffman,  S.  P.;  Sverd,  J.;  Clark,  J.;  Voeller,  K.   (1976a)  Lead  and hyper-
     activity:   behavioral  response  to  chelation:  a  pilot  study.   Am.  J.  Psychiatry  133:
     1155-1158.

                                          12-306

-------
David, 0.  J.; Hoffman, S.;  McGann, B.; Sverd, J.; Clark, J. (1976b) Low lead levels and mental
     retardation. Lancet 2(8000): 1376-1379.

David, 0.  J.;  Hoffman,  S.  P.; Sverd, J.; Clark, J. (1977) Lead and hyperactivity: lead levels
     among hyperactive children.  J.  Abnorm. Child Psychol. 5: 405-416.

David, 0.  J.;  Clark,  J.;  Hoffman, S. (1979a) Childhood lead poisoning: a re-evaluation. Arch.
     Environ. Health 34:  106-111.

David, 0. J.;  Hoffman,  S.; Kagey,  B.  (1979b) Sub-clinical lead  levels  and behavior in chil-
     dren.  In:  Hemphill,  D.  D., ed. Trace substances in environmental  health- XIII: [pro-
     ceedings  of  University  of Missouri's  13th  annual  conference  on  trace  substances  in
     environmental health]; June; Columbia, MO. Columbia,  MO: University of Missouri-Columbia;
     pp.  52-58.

David, 0.  J.;  Wintrob,  H.  L.;  Arcoleo,  C.  G.  (1982a) Blood  lead stability. Arch. Environ.
     Health 37: 147-150.

David, 0. J.;  Grad,  G.;  McGann, B.; Koltun,  A. (1982b) Mental  retardation  and "nontoxic" lead
     levels. Am. J. Psychiatry 139:  806-809.

David, 0. J.;  Hoffman,  S.; Clark,  J.; Grad,  G.;  Sverd, J.  (1983)  Penicillamine  in  the treat-
     ment  of  hyperactive   children with  moderately  elevated  lead  levels.   In:  Rutter,  M.;
     Russell Jones,  R.,  eds.  Lead  versus  health:  sources and effects  of  low level lead ex-
     posure. New York, NY:  John  Wiley & Sons; pp.  297-317.

David, 0.  J.;   Katz,  S. ;  Arcoleo,  C.  G.;  Clark,  J.  (1985)  Chelation therapy in children as
     treatment of sequelae  in severe lead  toxicity.  Arch.  Environ.  Health 40:  109-113.

Davies,  J.   M.   (1984)  Lung  cancer mortality  among  workers  making  lead  chromate  and zinc
     chromate pigments at three  English  factories. Br.  J.  Ind.  Med.  41:  158-169.

Davis, J. M.  (1982)  Ethological approaches to  behavioral  toxicology.  In: Mitchell,  C.  L., ed.
     Nervous  system  toxicology. New  York,  NY:  Raven Press;  pp.  29-44.   (Dixon,  R.  L., ed.
     Target  organ toxicology  series).

Davis,  J.  R. ;  Abrahams,   R.  H. ;  Fischbein,  W.  I.;  Fabrega,   E.  A.  (1968) Urinary  delta-
     ami nolevulinic  acid (ALA)  levels  in  lead poisoning:  II.  correlation  of  ALA values with
     clinical  findings  in  250   children with suspected lead ingestion.  Arch.  Environ.  Health
     17:  164-171.

de  la  Burde, B.; Choate, M.  S., Jr. (1972)  Does  asymptomatic  lead exposure  in  children  have
     latent  sequelae? J. Pediatr.  (St. Louis) 81:  1088-1091.

de  la  Burde, B.;  Choate, M. S.,  Jr.  (1975) Early  asymptomatic lead exposure and development  at
     school  age.  J.  Pediatr.  (St.  Louis)  87:  638-642.

Deknudt,  G.;  Leonard,  A.;  Ivanov,  B. (1973) Chromosome  aberrations  observed in male  workers
     occupationally  exposed to  lead. Environ. Physiol. Biochem. 3:  132-138.

Deknudt,  G.;  Colle,  A.;  Gerber, G. B.  (1977a) Chromosomal abnormalities  in  lymphocytes from
     monkeys poisoned with  lead. Mutat.  Res.  45:  77-83.
                                           12-307

-------
Deknudt, G. ; Manuel,  Y. ;  Gerber, G. B. (1977b) Chromosomal aberrations in workers profession-
     ally exposed to lead. J.  Toxicol. Environ. Health 3: 885-891.

Deknudt, G.;  Deminatti,  M.   (1978)  Chromosome  studies  in  human lymphocytes  after  HI vitro
     exposure to metal salts.  Toxicology 10: 67-75.

Deknudt, G.;  Gerber, G. B. (1979) Chromosomal aberrations in bone-marrow cells  of mice given  a
     normal or  a calcium-deficient  diet  supplemented with various  heavy  metals.  Mutat. Res.
     68: 163-168.

Der, R. ; Fahim,  Z. ;  Hilderbrand, D. ; Fahim, M. (1974) Combined effect of lead  and low protein
     diet  on  growth,  sexual  development,  and  metabolism  in  female  rats.  Res. Commun. Chem.
     Pathol.  Pharmacol. 9: 723-738.

Dessi,  S.;  Batetta, B.;  Laconi, E. ;  Ennas,  C.;  Pani,  P.  (1984)  Hepatic  cholesterol in lead
     nitrate induced liver hyperplasia. Chem. Biol. Interact. 48: 271-279.

Dieter,  M.  P.;  Finley,  M.  T.  (1979) 6-Aminolevulinic acid  dehydratase enzyme  activity in
     blood, brain, and liver of  lead-dosed ducks. Environ.  Res. 19: 127-135.

Dietrich,  K.  N. ; Krafft,  K.  M. ; Pearson,  D.  T. ;  Bornschein,  R.  L.;  Hammond,  P.  B.; Succop,
     P. A.  (1985a)  Postnatal  lead exposure and early sensorimotor development. Environ. Res
     38: 130-136.

Dietrich,  K.  N.;  Krafft,  K.  M.; Pearson,  D. T.; Harris, L. C.; Bornschein, R.  L.; Hammond, P.
     B. ; Succop,  P.  A.  (1985b) Contribution  of  social  and  developmental  factors  to lead
     exposure during the first year of life. Pediatrics  75: 1114-1119.

Dietz,  D.  D. ;  McMillan,  D.   E.;  Grant,   L.  D.;  Kimmel,  C.  A.  (1978)  Effects  of  lead  on
     temporally-spaced responding in rats.  Drug Chem.  Toxicol.  1: 401-419.

Dietz,  D.  D.;  McMillan,  D.  E.; Mushak,  P.  (1979) Effects of  chronic lead administration on
     acquisition  and  performance  of  serial  position  sequences  by  pigeons.  Toxicol.  Appl
     Pharmacol.  47:  377-384.

Dilts,  P.  V., Jr.;  Ahokas, R. A. (1979) Effects of dietary lead and zinc on pregnancy.  Am. J
     Obstet.  Gynecol. 135: 940-946.

Dilts,  P.  V.,  Jr.; Ahokas,  R.  A.   (1980)  Effects of  dietary lead  and  zinc  on  fetal organ
     growth.  Am.  J.  Obstet. Gynecol. 136:  889-896.

Dingwall-Fordyce, I.;  Lane, R.  E.  (1963)  A  follow-up study  of lead workers. Br. J.  Ind. Med.
     20: 313-315.

DiPaolo, J.  A.;  Nelson,  R.   L. ;  Casto,  B.  C.  (1978) Jji  vitro  neoplastic  transformation of
     Syrian hamster  cells  by  lead acetate and  its  relevance to environmental  carcinogenesis.
     Br. J. Cancer 38:  452-455.

Dolinsky,  Z.  S.;  Burright,  R. G. ; Donovick,  P.  J.;  Glickman,  L. T.;  Babish, J. ; Summers,  B. ;
     Cypess,   R.  H.   (1981) Behavioral  effects of  lead  and Toxocara cam's  in mice. Science
     (Washington, DC) 213: 1142-1144.
                                          12-308

-------
Donald,  J.   M.;   Cutler,  M.  G.;  Moore,  M.   R. ;  Bradley,  M.   (1981)  Development  and social
     behaviour  in mice  after prenatal  and  postnatal  administration  of low  levels  of lead
     acetate. Neuropharmacology 20:  1097-1104.
Donovan,  M.  P.;  Schein,  L. G.;  Thomas,  J.  A. (1980)  Inhibition of androgen-receptor inter-
     action  in mouse  prostate gland cytosol  by  divalent metal  ions.  Mol.  Pharmacol.  17:
     156-162.
Dresner,  D.  L.;  Ibrahim, N. G.;  Mascarenhas,  B.  R.; Levere,  R.  D.  (1982)  Modulation of bone
     marrow  heme  and protein synthesis by trace elements.  Environ. Res. 28:  55-66.
Drew,  W.  G.; Kostas, J.; McFarland,  D.  J. ;  De Rossett,  S.  E.  (1979)  Effects  of  neonatal lead
     exposure  on  apomorphine-induced  aggression  and stereotypy  in  the  rat.  Pharmacology  18:
     257-262.
Driscoll,  J.  W.; Stegner,  S. E.  (1976)  Behavioral  effects of  chronic   lead  ingestion  on
     laboratory rats. Pharmacol.  Biochem. Behav.  4:  411-417.
Driscoll,  J. W.;  Stegner,  S.  E.  (1978) Lead-produced changes  in  the  relative rate of open
     field activity  of  laboratory rats.  Pharmacol.  Biochem.  Behav. 8:  743-747.
Dubas,  T.  C.;  Hrdina,  P. D.  (1978) Behavioural and neurochemical consequences of neonatal  ex-
     posure  to  lead  in  rats. J. Environ.  Pathol.  Toxicol.  2:  473-484.
Dubas,  T. C.;  Stevenson,  A.; Singhal,  R.   L.;  Hrdina,  P.  D. (1978)  Regional alterations of
     brain   biogenic  amines  in   young  rats  following  chronic   lead  exposure.  Toxicology  9:
     185-190.
Dyck,  P.  J.; Windebank,  A.  J.;  Low,  P. A.;  Baumann, W.  J. (1980)  Blood nerve barrier in  rat
     and  cellular  mechanisms of  lead-induced segmental  demyelination.  J. Neuropathol.  Exp.
     Neurol. 39:  700-709.
Eales, W.  (1905)  Lead as an abortifacient [letter]. Br. Med. J. 1: 653.
Edelstein,  S.; Fullmer,  C.  S.; Wasserman,  R.  H.  (1984) Gastrointestinal  absorption of lead in
     chicks:  involvement  of  the cholecalciferol  endocrine  system.  J.   Nutr.   114:  692-700.
Elardo, R.;  Bradley, R.; Caldwell,  B.  M.  (1975)  The relation of infants' home environments to
     mental  test  performance  from six  to  thirty-six  months: a longitudinal analysis.  Child
     Dev.  46:  71-76.
Ely,  D.  L.; Mostardi,  R.  A.; Woebkenberg,  N.; Worstell, D.  (1981) Aerometric  and hair trace
     metal  content in learning-disabled children.  Environ. Res.  25: 325-339.
Emmerson, B.  T.  (1963) Chronic  lead  nephropathy:  the  diagnostic use  of calcium EDTA and  the
      association with gout. Australas. Ann. Med.  12: 310-324.
 Emmerson, B.  T.  (1968) The clinical  differentiation of  lead  gout from primary gout.  Arthritis
      Rheum.  11: 623-634.
 Emmerson, B. T.  (1973) Chronic lead nephropathy.  Kidney  Int.  4:  1-5.
 Emmerson, B. T.  (1980) Uricosuric diuretics.  Kidney  Int.  18:  677-685.

                                           12-309

-------
Emmerson, B.  T.;  Mirosch,  W.;  Douglas, J.  B.  (1971)  The  relative  contributions  of tubular
     reabsorption and secretion to urate excretion in lead nephropathy. Aust. N.  Z.  J. Med  4-
     353-362.

Englert,  N.  (1978) Messung der peripheren motorischen Nervenleitgeschwindigkeit an Erwachsenen
     und   Kindern  mit  erhb'htem Blutbleispiegel  [Measurement  of  peripheral  motor  nerve con-
     duction velocity  in  adults  and children with elevated  blood lead levels].  BGA Ber. (!)•
     108-117.

Englert,   N.   (1980)  Periphere   motorische   Nervenleitgeschwindigkeit   bei   Probanden  mit
     beruflicher Blei-Exposition  [Peripheral  motor nerve conduction velocity in test subjects
     occupationally  exposed  to   lead].  Arbeitsmed.  Sozialmed.  Praeventivmed.   15:  254-260.

Ennis, J. M. ;  Harrison,  H.  E. (1950) Treatment of lead encephalopathy with BAL (2,3-dimercap-
     topropanol).  Pediatrics 5: 853-868.

Epstein,  S.  S.; Mantel, N. (1968) Carcinogenicity of tetraethyl lead.  Experientia 24: 580-581.

Erenberg, G.;  Rinsler, S.  S.;  Fish,  B.  G.   (1974)  Lead neuropathy  and  sickle  cell disease
     Pediatrics 54: 438-441.

Ernhart,  C.  B.  (1983)  Response to appendix 12-C:  independent peer-review of selected studies
     concerning neurobehavioral effects of lead exposures in  nominally asymptomatic children:
     official  report of  findings  and  recommendations  of  an  interdisciplinary  expert  review
     committee. Available  for  inspection  at:  U.S.  Environmental  Protection  Agency, Central
     Docket Section, Washington, DC; docket no. ECAO-CD-81-2IIA.E.C.1.30.

Ernhart,   C.  B.  (1984) Comments on  Chapter 12,  Air Quality Criteria  for  Lead.   Available for
     inspection at:  U.S.  Environmental Protection Agency, Central Docket  Section, Washington
     DC;  docket no. ECAO-CD-81-2IIA.E.C.I.30.

Ernhart,  C.  B.;  Landa, B. ;  Schell, N.  B.  (1981)  Subclinical  levels of lead and developmental
     deficit - a multivariate follow-up reassessment. Pediatrics  67: 911-919.

Ernhart,   C.  B. ;  Landa,  B.;  Wolf,  A.  W.  (1985)  Subclinical lead   level  and  developmental
     deficit: reanalyses of data.  0. Learning Disabilities 18:  475-479.

Eskew, A.  E.; Crutcher,  J.  C.;  Zimmerman,  S.  L.;  Johnston, G.  W.;  Butz,  W.  C.  (1961) Lead
     poisoning resulting from illicit alcohol consumption. J.  Forensic Sci. 6: 337-350.

Eubanks,   S.  W.;  Patterson,  J.  W. ; May, D. L. ;  Aeling, J.  L.  (1983)  The porphyrias.  Int.  J
     Dermatol. 22: 337-347.

Ewers, U.;  Erbe,  R.  (1980) Effects  of lead,  cadmium and mercury on brain adenylate cyclase
     Toxicology 16: 227-237.

Ewers, U. ;  Stiller-Winkler,  R. ;   Idel, H.  (1982)  Serum  immunoglobulin, complement C3, and
     salivary IgA levels  in lead workers. Environ. Res. 29:  351-357.

Exon,  J.  H. ;  Koller,  L.  D.; Kerkvliet,  N.  I.  (1979) Lead-cadmium  interaction:  effects on
     viral-induced mortality  and  tissue residues  in mice.  Arch.  Environ. Health 34: 469-475.
                                          12-310

-------
Expert Committee on  Pediatric  Neurobehavioral  Evaluations.  (1983) Independent peer review of
     selected  studies   concerning  neurobehavioral  effects  of  lead  exposures  in  nominally
     asymptomatic  children:  official  report of  findings  and recommendations  of  an  inter-
     disciplinary  expert  review committee.  Available  for inspection at:  U.S.  Environmental
     Protection Agency, Environmental  Criteria  and Assessment Office, Research Triangle Park,
     NC.

Expert Committee  on  Trace Metal  Essentiality.  (1983) Independent  peer  review  of selected
     studies  by Drs.  Kirchgessner  and  Reichlmayr-Lais  concerning  the  possible nutritional
     essentiality  of  lead:  official  report of  findings  and recommendations  of  an  inter-
     disciplinary  expert  review committee.  EPA  report no. EPA-600/8-83-028A.  Available for
     inspection  at:   U.S.   Environmental   Protection   Agency,   Environmental  Criteria  and
     Assessment Office, Research Triangle Park, NC.

Eyden, B.  P.;  Maisin,  J.  R. ; Mattelin, G. (1978) Long-term effects of dietary lead  acetate on
     survival,  body  weight  and seminal cytology  in  mice.  Bull.  Environ. Contain. Toxicol. 19:
     266-272.

Fahim, M.  S.;  Fahim, Z. ;  Hall, D.  G.  (1976) Effects of subtoxic lead levels on pregnant women
     in the state of Missouri. Res.  Commun.  Chem. Pathol.  Pharmacol.  13:  309-331.

Faith,  R.   E.;  Luster, M.  I.;  Kimmel,   C.  A.   (1979)   Effect of  chronic  developmental   lead
     exposure on cell-mediated immune  functions.  Clin.  Exp. Immunol.  35:  413-420.

Fejerman,  N.;  Gimenez,  E.  R.; Vallejo, N. E.;  Medina,  C.  S. (1973)  Lennox's syndrome and  lead
     intoxication.  Pediatrics 52:  227-234.

Feldman,  R.  G.;   Haddow,   J. ;  Chisolm,  J.   J.  (1973a) Chronic  lead  intoxication  in  urban
     children:  motor nerve conduction velocity studies.  In: Desmedt, J.; Karger,  S., eds. New
     developments  in electromyography and clinical  neurophysiology:  v.  2.  Basel,  Switzerland:
     S. Karger; pp.  313-317.

Feldman,  R.  G.;  Haddow,  J.;  Kopito,  L. ;  Schwachman, H.  (1973b)  Altered   peripheral  nerve
     conduction velocity. Am. J. Dis.  Child  125:  39-41.

Felman,  R.  G.; Hayes,  M. K.;  Younes,  R.; Aldrich,  F.  D.  (1977)  Lead neuropathy  in  adults and
     children.  Arch. Neurol. 34: 481-488.

Ferm,  V.   H.   (1969)  The synteratogenic  effect  of  lead and  cadmium.  Experientia  25: 56-57.

Ferm,  V.  H. ; Carpenter, S. J.  (1967)  Developmental malformations  resulting  from the adminis-
     tration  of lead salts. Exp. Mol.  Pathol. 7:  208-213.

Ferm,  V.   H.;  Ferm,  D. W.  (1971)  The specificity of  the teratogenic  effect of lead in the
     golden hamster.  Life  Sci.  10: 35-39.

Fessel, W.  J.  (1979) Renal  outcomes  of gout  and hyperuricemia. Am.  J. Med.  67: 74-82.

Filkins,  J.  P.  (1970) Bioassay of endotoxin  inactivation in the  lead-sensitized  rat.  Proc.
      Soc.  Exp.  Biol.  Med.  134:  610-612.

Filkins,  J. P.; Buchanan,  B.  J.  (1973) Effects  of lead acetate on sensitivity to shock, intra-
      vascular carbon and  endotoxin clearances,  and hepatic endotoxin detoxification. Proc. Soc.
      Exp.  Biol. Med.  142:  471-475.

                                           12-311

-------
Fineberg, S. K.; Altschul, A. (1956) The nephropathy of gout. Ann. Intern. Med. 44: 1182-1194.

Finelli, V.  N.; Klauder, D. S.; Karaffa, M. A.; Petering, H. G. (1975) Interaction of zinc and
     lead on 6-aminolevulinate dehydratase. Biochem. Biophys. Res. Commun. 65: 303-311.

Fischbein, A.;  Alvares, A. P.; Anderson, K. E.; Sassa, S.; Kappas, A. (1977) Lead intoxication
     among  demolition  workers:  the effect  of lead on the hepatic cytochrome  P-450 system in
     humans, J. Toxicol. Environ.  Health 3: 431-437.

Fischbein,  A.;  Rice,  C. ;  Sarkozi,  L.; Kon,  S.  H. ; Petrocci,  M.; Selikoff,  I.  J.  (1979) Ex-
     posure to lead in firing ranges.  J. Am. Med. Assoc. 241: 1141-1144.

Fischbein,  A.;  Thornton, J. ;  Blumberg, W. E.;  Bernstein,   J. ;  Valciukas,  J. A.;  Moses, M. ;
     Davidow, B.; Kaul, B.; Sirota, M.; Selikoff, I. J. (1980) Health status of cable splicers
     with low-level exposure to lead:  results of  a clinical survey. Am. J. Public Health 70-
     697-700.

Flatmark, T.;  Romslo,  I.  (1975)  Energy-dependent accumulation of iron  by  isolated rat  liver
     mitochondria. J.  Biol. Chem.  250:  6433-6438.

Fleischer,  N.; Mouw,  D.  R.; Vander, A. J.  (1980) Chronic effects of  lead  on renin and  renal
     sodium excretion. J. Lab. Clin. Med.  95:   759-770.

Flynn, J. C.;  Flynn,  E. R.;  Patton,  J. H.  (1979)  Effects of  pre-  and post-natal  lead on af-
     fective behavior and  learning in the  rat.  Neurobehav.  Toxicol.  1 (Suppl.  1):  93-103.

Fonzi, S.; Penque, L.; Raddi, R. (1967a) Processi immunitari nella intossicazione sperimentale
     da piombo. Nota II. Comportamento  delle globuline anticorpali in corso di intossicazione,
     prima  e durante  stimolo vaccinico [Immunitary processes  in experimental  lead poisoning.
     Note II. Behavior of anti-body globulins  before and during active immunization]. Lav. Dm
     19: 200-205.

Fonzi, S.; Penque, L.; Raddi, R. (1967b) Processi immunitari nella intossicazione sperimentale
     da  piombo.  Nota VI.  Variazioni  degli anticorpi  antitifici (completi  ed incompleti) in
     corso  di   immunizzazione  attiva  specifica  [Immunitary processes  in  experimental  lead
     poisoning.  Note.  VI.  The  behavior of antithyphus antibodies  (complete  and  incomplete)
     during active immunization].  Lav.  Urn. 19: 324-328.

Form',  A.;   Cambiaghi,   G.;   Secchi,  G.  C.  (1976)  Initial occupational  exposure  to   lead:
     chromosome and biochemical findings.  Arch. Environ. Health 31:   73-78.

Forni, A.;  Sciame,  A.;  Bertazzi,  P. A.; Alessio, L. (1980)  Chromosome and biochemical studies
     in women occupationally exposed to lead.   Arch. Environ. Health  35: 139-146.

Forni,  A.;   Sciame, A.; Goffredi,  M;  Ortisi, E.  (1981) Effetto del  tempo di  coltura  sulla
     frequenza di  aberrazioni  cromosomiche nei linfociti di esposti a piombo e di controlli,
     Atti 5th  convegno nazionale di citogenetica medica; April 1980; Ancona.

Fouts,  P.  J.;  Page,   I.  H.  (1942) The effect  of chronic  lead poisoning  on arterial   blood
     pressure  in dogs. Am. Heart J. 24: 329-331.

Fowler,  B.   A.  (1978)  General  subcellular  effects of  lead,  mercury,  cadmium,  and arsenic.
     Environ. Health Perspect. 22:  37-41.


                                          12-312

-------
Fowler, B.  A.;  Kimmel,  C.  A.; Woods,  J.  S. ;  McDonnell,  E.  E.; Grant,  L.  D.  (1980) Chronic
     low-level lead toxicity  in  the rat: III.  an  integrated  assessment of long-term toxicity
     with special  reference to the kidney.  Toxicol. Appl.  Pharmacol.  56: 59-77.

Fowler, B. A.; Squibb, K. S.; Oskarsson, A.; Taylor, J. A.; Carver, G. T. (1981a) Lead-induced
     alteration of  renal mitochondrial  membrane structure and function.  Toxicologist 1: 19.

Fowler, B.  A. ;  Squibb,  K.  S. ; Oskarsson, A. (1981b) Mitochondrial membrane potential (A4*) and
     energy-linked membrane  transformation:  inhibition by Pb binding  in vitro.  J.  Cell  Biol.
     91:  287a.

Fox,  D.  A.;  Sillman,  A. J.  (1979) Heavy  metals  affect  rod,  but  not  cone, photoreceptors.
     Science (Washington, DC) 206: 78-80.

Fox, D. A. ;  Wright,  A.  A.  (1982) Evidence that  low-level developmental  lead  exposure produces
     toxic amblyopia.  Soc.  Neurosci. Abstr. 8: 81.

Fox, D. A.;  Lewkowski,  J.  P.; Copper, G. P.  (1977) Acute and chronic  effects of  neonatal  lead
     exposure on  development of the visual evoked response in  rats. Toxicol.  Appl. Pharmacol.
     40:  449-461.

Fox, 0. A.; Overmann, S. R.; Woolley, D. E.  (1978) Early  lead exposure and  ontogeny of  seizure
     responses in the rat.  Toxicol. Appl. Pharmacol. 45:  270.

Fox,  0.  A.;  Overmann,  S.  R.;  Woolley,  D.  E.   (1979)  Neurobehavioral ontogeny  of neonatally
     lead-exposed  rats:  II.  maximal   electroshock  seizures   in  developing  and  adult  rats.
     Neurotoxicology 1:  149-170.

Fox,  D.  A.; Wright,  A.  A.;  Costa,  L. G. (1982)  Visual  acuity deficits following  neonatal lead
     exposure: cholinergic interactions. Neurobehav. Toxicol. Teratol. 4:  689-693.

Freedman,  M.  L. ;  Rosman,   J.  (1976)  A rabbit reticulocyte  model   for  the role  of  hemin-
     controlled represser in  hypochromic anemias.  J. Clin.  Invest. 57: 594-603.

Freeman,  R.   (1965)  Reversible myocarditis due  to  chronic  lead poisoning  in childhood.  Arch.
     Dis.  Child. 40: 389-393.

Fujita,  H. ; Orii, Y. ;  Sano,  S.  (1981) Evidence  of increased synthesis  of  6-amino-levulinic
     acid dehydratase  in experimental  lead-poisoned  rats.   Biochim.  Biophys. Acta  678:  39-50.

Fukumoto,  K. ; Karai,  I. ; Horiguchi,  S.  (1983)  Effect  of  lead on erythrocyte membranes.  Br.  J.
      Ind.  Med. 40: 220-223.

Fullerton,   P.  M.   (1966)   Chronic  peripheral   neuropathy  produced  by  lead  poisoning  in
      guinea-pigs. J.  Neuropathol.  Exp.  Neurol.  25:  214-236.

Fullmer,  C.  S.; Edelstein,  S.;  Wasserman,  R. H.  (1985)  Lead-binding properties of intestinal
      calcium-binding  proteins.  J.  Biol.  Chem.  260:  6816-6819.

Furst, A.; Schlauder, M.; Sasmore,  D.  P.  (1976) Tumorigenic activity of lead chromate.  Cancer
      Res.  36:  1779-1783.

Gaffey,  W. R. (1980) Occupational  lead exposure: what are  the risks [letter in response to a
      letter by  Kang]?  Science (Washington, DC) 208:  130-131.

                                           12-313

-------
Gainer, J.  H.  (1973)  Activation of  the Rauscher  leukemia  virus by  metals.  J. Natl. Cancer
     Inst. (U.S.) 51: 609-613.

Gainer, J.  H.  (1974)  Lead aggravates  viral  disease and  represses  the antiviral activity  of
     interferon inducers. Environ. Health Perspect. 7: 113-119.

Gainer, J. H.  (1977a)  Effects on interferon of heavy metal excess and  zinc deficiency. Am.  J.
     Vet.  Res.  38: 863-867.

Gainer, J. H.  (1977b)  Effects of heavy metals and of deficiency  of  zinc on mortality  rates  in
     mice infected with encephalomyocarditis virus. Am. J. Vet. Res. 38: 869-872.

Gale, T.  F.  (1978)  A variable embryotoxic  response to lead  in different  strains of hamsters.
     Environ. Res. 17:  325-333.

Gallagher, K.;  Matarazzc)., W. J,.; Gray, I.+ (1979) Trace metal  modification  of immunocompetence:
     II.  effect  of  Pb2  ,  Cd2 ,  and  Cr3  on  RNA  turnover,   hexokinase activity, and  blasto-
     genesis during B-lymphocyte  transformation  ui  vitro.   Clin.  Immunol.  Immunopathol.  13:
     369-377.

Galle,  P.; Morel-Maroger,  L.  (1965)  Les  lesions  renales  du  saturnisme humain  et experimental
     [Renal lesions of clinical and experimental lead poisoning]. Nephron  2: 273-286.

Gant, V. A. (1938) Lead poisoning. Ind. Med. 7: 679-699.

Garcia-Cahero,  R.;  Kapoor,  S.  C.; Rabinowitz, M.; van Rossum, G. D. V. (1981)  Effect  of  Pb on
     02  consumption   and   substrate  transport   in   isolated  renal   proximal  tubules   and
     mitochondria. Pharmacologist 23: 190.

Garrod, A. B. (1859) Changes in the kidneys of gouty subjects. In: The  nature and treatment of
     gout and rheumatic gout. London, United Kingdom: Walton  and  Maberly;  pp. 236-249.

Garza-Chapa, R.; Leal-Garza,  C.  H.; Molina-Ballesteros,  G. (1977)  Analisis  cromosdmico  en
     personas  profesionalmente  expuestas  a contaminacion  con plomo  [Chromosome analysis  in
     subjects  exposed  professionally to  lead contamination].   Arch.   Invest.  Med.  8: 11-20.

Ga'th,  J.; Thiess,  A.  M.  (1972)  Chromosomen-Untersuchungen  bei Chemiearbeitern  [Chromosome
     studies in chemical workers]. Zentralbl. Arbeitsmed. 22:  357-362.

Gaworski, C. L.;  Sharma, R.  P.  (1978)  The  effects of heavy  metals  on  [3H]thymidine uptake in
     lymphocytes. Toxicol.  Appl. Pharmacol. 46: 305-313.

Geist,  C.  R. ;  Balko, S.  W.  (1980)  Effects  of postnatal  lead acetate exposure  on activity and
     emotionality in developing laboratory rats. Bull. Psychon. Soc. 15: 288-290.

Geist,  C.  R. ;  Mattes,  B.  R.  (1979)  Behavioral effects of postnatal lead acetate exposure  in
     developing  laboratory rats. Physiol. Psychol. 7: 399-402.

Geist,  C.  R. ;  Praed,  J.  E.  (1982)  Chronic  lead  exposure   of  rats:   open-field performance.
     Percept. Mot. Skills 55: 487-490.

Geist,  C.  R.;  Balko,  S.  W. ;  Morgan, M. E.;  Angiak, R.  (1985)  Behavioral effects  following
     rehabilitation from postnatal exposure to lead acetate.  Percept. Mot.  Skills 60:  527-536.


                                          12-314

-------
Gelbard,  H.  A.;  Stern,  P.  H.;  U'Prichard, D.  C.  (1980)  la,25-dihydroxyvitamin  D3 nuclear
     receptors in the pituitary.  Science (Washington, DC) 209: 1247-1249.

Geppert, T.  (1882)  Chronische Nephritis nach Bleivergiftung [Chronic nephritis following lead
     poisoning], Dtsch. Med. Wochenschr. 8:  241-242.

Gerber, G. B.; Maes, J. (1978) Heme synthesis in the lead-intoxicated mouse embryo. Toxicology
     9: 173-179.

Gerber, G.  B.;  Maes, J.; Gilliavod,  N.;  Casale, G. (1978)  Brain biochemistry of infant mice
     and rats exposed to  lead. Toxicol. Lett. 2: 51-63.

Gerhardt,  R.  E.; Crecelius,  E.  A.;  Hudson, J.  B.  (1980)  Trace element content of moonshine.
     Arch. Environ.  Health  35: 332-334.

Giannattasio,  R. C.;  Bedo,  A.   V.;  Pirozzi,  M.  J.  (1952)  Lead  poisoning:  observations  in
     fourteen cases. Am.  J. Dis.  Child. 84:  316-321.

Giavini,  E.;  Prati,  M.;  Vismara,  C.  (1980)   Effects  of  cadmium,  lead  and copper  on  rat
     preimplantation embryos.  Bull.  Environ. Contain. Toxicol.  25:  702-705.

Gibson,  S.  L.  M.;  Goldberg, A.  (1970)  Defects in  haem synthesis in  mammalian tissues  in
     experimental lead  poisoning and experimental  porphyria.  Clin.  Sci.  38:  63-72.

Gibson,  J.  L.;  Love,  W.;  Hardie,  D.;  Bancroft,  P.;  Turner,  A.  J.   (1893) Notes on  lead-
     poisoning  as  observed among children  in Brisbane.  In:  Huxtable,  L.  R. ,  ed.  Intercolonial
     medical congress  of  Australasia:  transactions of  the 3rd session;  September  1892;  Sydney,
     Australia.  Sydney, Australia:  Charles Potter; pp.  76-83.

Gibson,  T.; Simmonds,  H. A.;  Potter,  C.;  Jeyarajah,  N.;  Highton,  J.  (1978) Gout  and  renal
     function.  Eur.  J.  Rheumatol.  Inflammation  1:  79-85.

Gibson,  T.;  Highton, J.; Potter,  C.;  Simmonds, H.  A.  (1980a) Renal  impairment and gout.  Ann.
     Rheum.  Dis.  39: 417-423.

Gibson,  T. ; Simmonds,  H. A.;  Potter,  C.;  Rogers, V.  (1980b)  A controlled study  of the effect
     of long term allopurinol  treatment  on renal function  in gout.  In:  Rapado,  A.;  Watts, R.
     W.  E.; DeBruyn, C.  H.  M. M., eds.  Purine metabolism in man-Ill clinical and therapeutic
     aspects.  New York, NY: Plenum Press; pp. 257-262.

Gietzen,  D.  W. ; Woolley, D.  E.  (1984) Acetylcholinesterase  activity  in the brain of rat pups
     and   dams   after  exposure  to  lead  via  the  maternal  water  supply.  Neurotoxicology  5:
     235-246.

Gillberg, C.;  Noren,   J.  G.;  Wahlstrb'm,  J.;   Rasmussen,  P.   (1982)  Heavy metals  and neuro-
     psychiatric disorders in six-year-old children:  aspects of dental lead  and cadmium. Acta
     Paedopsychiat.  48: 253-263.

Gittelman,  R. ;  Eskenazi,  B.  (1983)  Lead  and hyperactivity revisited: an  investigation of
      nondisadvantaged children.  Arch. Gen.  Psychiatry 40: 827-833.

Glickman,  L.;  Valciukas,  J.  A.; Lilis,  R.; Weisman,  I. (1984)  Occupational  lead exposure:
      effects on saccadic eye movements. Int. Arch. Occup. Environ. Health 54:  115-125.


                                            12-315

-------
Gmerek, D. E.; McCafferty, M. R.; O'Neill, K. J.; Melamed, B. R.; O'Neill, J. J. (1981) Effect
     of  inorganic  lead on  rat  brain  mitochondrial  respiration  and  energy  production.  J.
     Neurochem. 36: 1109-1113.

Goddard,  G.  A.;   Robinson,  J.  D.  (1976)  Uptake and release of  calcium  by rat brain synapto-
     somes. Brain Res. 110: 331-350.

Goldberg,  A.  (1968)  Lead  poisoning as  a  disorder of  heme  synthesis.  Semin.  Hematol.  5:
     424-433.

Goldberg,  A.  M. ;  Meredith,  P.  A.;  Miller,  S. ; Moore,  M. R.;  Thompson,  G.  G.  (1978) Hepatic
     drug  metabolism  and  haem  biosynthesis  in lead-poisoned  rats.  Br.  J.  Pharmacol.   62:
     529-536.

Goldman,  D. ;  Hejtmancik,  M.  R. ,  Jr.;   Williams,  B.   J. ;  Ziegler,  M.  G.   (1980)  Altered
     noradrenergic  systems  in the lead-exposed  neonatal  rat. Neurobehav.  Toxicol.  2: 337-343.

Goldman,  J.  M. ;  Vander,  A.  J. ;  Mouw,  D.  R.; Keiser,  J. ;  Nicholls,  M.  G.  (1981) Multiple
     short-term  effects of lead  on the  renin-angiotensin  system.  J.   Lab.   Clin.  Med.  97:
     251-263.

Goldstein, G.  W. ; Ar, D. (1983)  Lead activates calmodulin sensitive processes.  Life Sci.  33:
     1001-1006.

Goldstein,  G.  W.;  Asbury,  A.  K. ;  Diamond, I.  (1974)  Pathogenesis of lead  encephalopathy:
     uptake  of lead  and reaction of brain  capillaries.  Arch.  Neurol.  (Chicago) 31: 382-389.

Goldstein, G.  W. ; Wolinksy, J.  S. ;  Csejtey, J.  (1977)  Isolated  brain capillaries:  a model  for
     the  study of lead encephalopathy. Ann.  Neurol.  1:  235-239.

Goiter,  M. ;  Michaelson,  I.  A.   (1975)  Growth, behavior,  and  brain catecholamines  in  lead-
     exposed neonatal rats: a reappraisal. Science  (Washington,  DC) 187:  359-361.

Golubovich,  E.  Ya.;  Avkhimenko,  M.  M. ;  Chirkova,  E. M.  (1968) Biochemical and morphological
     changes  in  the  testicles  of  rats  induced by  small doses  of  lead. Toksikol. Nov.  Prom.
     Khim. Veschestv  10: 63-73.

Gonick,  H.  C. ;  Rubini,  M.   E.; Gleason, I. 0.;  Sommers, S. C.  (1965) The renal  lesion in  gout.
     Ann. Intern. Med. 62:  667-674.

Gonzalez,  J.  J.; Werk,  E.  E. ;  Thrasher, K. ;  Loadholdt, C.  B.  (1978)  The renin  aldosterone
     system  and potassium levels  in  chronic  lead intoxication.  Clin. Res.  26: 47A.

Govoni,  S. ;  Montefusco,  0.; Spano,  P. F. ; Trabucchi, M.  (1978a) Effect  of chronic  lead  treat-
     ment  on brain dopamine synthesis and serum prolactin release in the rat.  Toxicol.  Lett.
     2:  333-337.

Govoni,  S.;  Spano,  P. F.;  Trabucchi, M.  (1978b) Neurochemical  changes induced  by  dietary lead
     chronic assumption. Dev. Toxicol. Environ.  Sci.  3: 381-385.

Govoni,  S.;  Memo, M.; Spano.  P. F.;  Trabucchi,  M.  (1979)  Chronic lead treatment differentially
     affects dopamine synthesis in  various rat  brain areas.  Toxicology 12:  343-349.
                                           12-316

-------
Govoni,  S.;  Memo, M.;  Lucchi,  L.;  Spano, P. F.;  Trabucchi,  M.  (1980) Brain  neurotransmitter
     systems and chronic lead intoxication.  Pharmacol. Res. Commun. 12: 447-460.

Govoni,  S.;  Lucchi,  L.; Battaini, F.; Spano,  P.  F.;  Trabucchi, M. (1984) Chronic  lead  treat-
     ment affects dopaminergic control of prolactin secretion  in rat pituitary.  Toxicol.  Lett.
     20: 237-241.

Goyer,  R.  A.  (1968)  The renal  tubule in lead poisoning:  I. mitochondrial swelling and  amino-
     aciduria. Lab.  Invest. 19: 71-77.

Goyer,  R.  A.  (1971) Lead  toxicity:  a problem in  environmental  pathology.  Am. J.  Pathol.  64:
     167-181.

Goyer,  R.  A.;  Krall, A. R. (1969a)  Further  observations on the  morphology and biochemistry of
     mitochondria  isolated from kidneys  of  normal  and lead intoxicated  rats.  Fed.  Proc.  Fed.
     Am. Soc. Exp. Biol. 28: 619A.

Goyer,  R.  A.; Krall,  A,  R.  (1969b) Ultrastructural  transformation  in  mitochondria isolated
     from  kidneys  of normal and lead-intoxicated rats.  J.  Cell Biol.  41:  393-400.

Goyer,  R.  A.;  Moore, J. F. (1974)  Cellular  effects  of lead.  Adv.  Exp. Med.  Biol.  48: 447-462.

Goyer,  R.  A.; Rhyne,  B.  C.  (1973) Pathological effects  of  lead.  Int.  Rev.  Exp.  Pathol.  12:
     1-77.

Goyer,  R.  A.; Wilson,  M.  H.  (1975) Lead-induced inclusion bodies:  results  of ethylenediamine-
     tetraacetic acid  treatment.  Lab. Invest.  32:  149-156.

Goyer,  R.  A.; Leonard,  D.  L.;  Moore, J. F.; Rhyne,  B.; Krigman, M.  R. (1970a) Lead dosage and
     the role of the intranuclear inclusion  body:  an experimental  study.  Arch. Environ.  Health
     20:  705-711.

Goyer,  R.  A.; Leonard,  D.  L.;  Bream, P.  R.;  Irons, T.  G. (1970b) Aminoaciduria in experimental
      lead  poisoning. Proc.  Soc.  Exp. Biol.  Med.  135:  767-771.

Goyer,  R.  A.; Tsuchiya, K.; Leonard, D.  L.;  Kahyo, H.  (1972) Aminoaciduria in Japanese workers
      in the lead and cadmium  industries. Am. J.  Clin.  Pathol.  57:  635-642.

Granahan,  P.; Huber,  A. M. (1978)  Effect of  ingested lead on  prenatal  development and trace
      element deposition in the rat. Fed. Proc.  Fed.  Am. Soc.  Exp.  Biol.  37:  895.

Grandjean, P.  (1979) Occupational  lead exposure in Denmark:  screening with the haematofluoro-
      meter.  Br.  J.  Ind. Med.  36:  52-58.

Grandjean,  P.;   Lintrup,   J.  (1978)  Erythrocyte-Zn-protoporphyrin  as  an  indicator  of  lead
      exposure.  Scand.  J. Clin.  Lab.  Invest.  38: 669-675.

Grandjean,  P.;  Arnvig,  E.;  Beckmann,  J.  (1978)  Psychological dysfunctions in  lead-exposed
      workers:  relation to biological parameters of exposure.  Scand. J. Work  Environ.  Health 4:
      295-303.

Grandjean,  P.;  Wulf,  H.   C.;  Niebuhr,  E.  (1983)  Sister  chromatid  exchange  in  response  to
      variations  in occupational lead exposure.  Environ.  Res.  32: 199-204.


                                           12-317

-------
Granick, J.  L.;  Sassa,  S.;  Granick,  S.;  Levere,  R.  D.;  Kappas,  A.  (1973)  Studies  in  lead
     poisoning:  II. correlation between the ratio of activated to  inactivated  6-aminolevulim'c
     acid  dehydratase of  whole  blood and the  blood  lead  level.  Biochem. Med.  8:  149-159.

Granick, J.  L.;  Sassa,  S.;  Kappas,  A.  (1978) Some biochemical  and  clinical  aspects of  lead
     intoxication.  Adv. Clin. Chem. 20: 288-339.

Grant, L. D.; Kiminel, C. A.; West, G.  L.; Martinez-Vargas, C. M. ;  Howard, J. L.  (1980) Chronic
     low-level  lead toxicity  in  the  rat:  II. effects  on postnatal  physical and behavioral
     development. Toxicol. Appl.  Pharmacol. 56: 42-58.

Gray, L. E.,  Jr.;  Reiter, L.  (1977)  Lead-induced developmental  and behavioral  changes  in the
     mouse. Presented at the 16th annual meeting of the Society  of  Toxicology; March; Toronto,
     ON, Canada.  Toxicol. Appl. Pharmacol. 41: 140.

Greenbaum, D.; Ross, J. H.; Steinberg, V. L. (1961) Renal  biopsy in gout. Br.  Med. J. 1(5238):
     1502-1504.

Greenfield,  I.;  Gray, I. (1950)  Lead poisoning;  IX.  the  failure  of  lead poisoning to  affect
     the heart and blood vessels.  Am.  Heart J. 39: 430-435.

Greengard,  J. ;  Adams,  B.;  Berman,   E.  (1965) Acute  lead encephalopathy  in  young children:
     evaluation  of therapy with  a .corticosteroid and  moderate  hypothermia.  J.  Pediatr.  (St.
     Louis) 66:  707-711.

Gross,  S.  B.  (1981)  Human oral  and  inhalation  exposures to lead:  summary of Kehoe balance
     experiments. J. Toxicol. Environ. Health  8: 333-377.

Gross,  S.  B.;  Pfitzer,  E.  A.;  Yeager,  D.  W.;  Kehoe,  R. A.  (1975) Lead  in human tissues.
     Toxicol. Appl. Pharmacol.  32: 638-651.

Gross-Selbeck, E. ;  Gross-Selbeck, M.  (1981)   Changes  in  operant  behavior  of rats exposed to
     lead at  the accepted no-effect  level. Clin. Toxicol.  18: 1247-1256.

Grundt,  I.  K.;  Neskovic, N.  M. (1980) Comparison of the inhibition by methyl-mercury and  tri-
     ethyllead of galactolipid  accumulation in rat brain.  Environ.  Res.  23: 282-291.

Grundt,  I.  K.;  Amitiitzbdll,  T.;  Clausen,  J.   (1981)  Triethyllead treatment of  cultured brain
     cells: effect on accumulation of radioactive precursors  in  galactolipids. Neurochem.  Res.
     6:  193-201.

Gudbrandsson, T.;  Hansson,  L.; Herlitz, H.; Lindholm,  L.; Nilsson, L. A. (1981) Immunological
     changes  in  patients with  previous  malignant  essential   hypertension.  Lancet 1(8217):
     406-408.

Guerit,  J. M.; Meulders, M.; Amand, G.; Roels, H. A.; Buchet, J.-P.;  Lauwerys, R.;  Bruaux, P.;
     Claeys-Thoreau,  F. ;  Ducoffre,  G.; Lafontaine, A.  (1981) Lead neurotoxicity in  clinically
     asymptomatic  children  living  in  the vicinity  of  an  ore smelter.  Clin.  Toxicol.  18:
     1257-1267.

Gull, W. W.;  Sutton,  H. G. (1872) On  the pathology of the  morbid state commonly  called chronic
     Bright's disease with contracted kidney  ("arterio-capillary fibrosis").  Medico Clin. Tr.
     55: 273-326.


                                          12-318

-------
Haas, T.; Wieck, A.  G.; Schaller, K. H.; Mache, K.; Valentin, H. (1972) Die usuelle Bleibelas-
     tung bei  Neugeborenen und  ihren  Muttern  [The  usual  lead  load in  new-born  infants and
     their mothers]. Zentralbl.  Bakteriol.  Parasitenkd.  Infektionskrankh.  Hyg.  Abt.  1: Grig.
     Reihe B 155: 341-349.

Habermann, E. ;  Crowell,  K. ;  Janicki, P. (1983)  Lead  and other metals can  substitute for Ca2
     in calmodulin.  Arch. Toxicol. 54:  61-70.

Hackett,  P.   L. ; Hess,  J.  0.;   Sikov,  M.   R.  (1978)  Lead  distribution and  effects  during
     development  in  the  rat.  In: Mahlum, D.  D.;  Sikov, M.  R.; Hackett,  P. L.; Andrew, F. D. ,
     eds.  Developmental   toxicology of energy-related  pollutants:   proceedings  of  the  17th
     annual  Hanford biology  symposium; October  1977;  Richland,  WA; pp.  505-519.  Available
     from: NTIS,  Springfield, VA; CONF-771017.

Hackett,  P.  L. ;  Hess,  J. 0.; Sikov, M. R.  (1979) Cross-piacental transfer  and distribution of
     inhaled or  ingested lead nitrate  in rats. Teratology  19:  28A.

Hackett,  P.  L.;  Hess,  J. 0.; Sikov, M.  R.  (1982a) Effect of dose level and  pregnancy on the
     distribution and  toxicity  of  intravenous lead  in rats.  J.  Toxicol.  Environ.  Health 9:
     1007-1020.

Hackett,  P.  L.;  Hess, J.  0.; Sikov, M.  R. (1982b) Distribution and effects  of  intravenous  lead
     in the  fetoplacental unit of the  rat. J.  Toxicol.  Environ. Health 9: 1021-1032.

Haeger,  B.   (1957)  Increased  content  of  a  6-aminolaevulic acid-like substance in urine  from
     workers  in  lead industry. Scand.  J. Clin.  Lab.  Invest. 9:  211-212.

Haeger-Aronsen,  B.  (1960) Studies on  urinary excretion of 6-aminolaevulic  acid  and other  haem
     precursors  in  lead  workers and  lead-intoxicated rabbits. Scand.  J.  Clin. Lab.  Invest.
     12(suppl. 47): 1-128.

Haenninen, H.;  Hernberg, S.; Mantere,  P.;  Vesanto,  R.;  Jalkanen,  M.  (1978) Psychological  per-
     formance  of subjects with low  exposure  to lead.  J.  Occup.  Med.  20:  683-689.

Haenninen,  H.;  Mantere, P.;  Hernberg, S. ;   Seppalainen,  A.  M. ; Kock,  B. (1979)  Subjective
     symptoms  in low-level exposure to lead.  Neurotoxicology 1:  333-347.

Hall,  A.; Cantab,  M.  D. (1905)  The  increasing use  of  lead as an abortifacient: a  series  of
     thirty  cases of plumbism. Br.  Med.  J.  1: 584-587.

Halliday, A. M.  ; McDonald, W.  I. (1981) Visual  evoked potentials.  In:  Stalberg,  E.;  Young,  R.
     R. ,  eds.  Clinical   neurophysiology.  London,  United  Kingdom:   Butterworths;  pp.  228-258.
     (Butterworths  international medical  reviews:  neurology 1).

Hamilton, D. L.  (1978)  Interrelationships  of lead and  iron retention in iron-deficient mice.
     Toxicol.  Appl.  Pharmacol.  46:  651-661.

Hammond,  P.  B.  (1971)  The effects of chelating agents on the tissue distribution and excretion
     of lead.  Toxicol. Appl.  Pharmacol.  18:  296-310.

Hammond,  P.  B.;  Lerner,  S.  I.;  Gartside,  P.  S.; Hanenson,  I. B.; Roda,  S.  B.; Foulkes, E. C.;
     Johnson, D.  R. ;  Pesce,  A.  J.   (1980)   The  relationship of  biological indices  of lead
     exposure to the  health  status of workers in a  secondary  lead  smelter. 0. Occup.  Med. 22:
     475-484.

                                           12-319

-------
Hammond, P. B.;  Hong,  C.  D. ; O'Flaherty, E. J. ; Lerner, S. I.; Hanenson, I. B. (1982) The  rat
     as an  animal  model  of lead  nephropathy.  In: Porter, G.,  ed.  Nephrotoxic mechanisms  of
     drugs and environmental agents. New York, NY: Plenum Press; pp. 267-277.

Hammond, P. B. ;  Bornschein, R.  L. ;  Succop,  P.  (1985) Dose-effect and dose-response  relation-
     ships of  blood  lead  to erythrocytic protoporphyrin in young children.  In: Bornschein,  R.
     L.; Rabinowitz, M. B., eds. The second  international conference on prospective studies  of
     lead; April 1984; Cincinnati, OH.  Environ. Res. 38: 187-196.

Hansen, K.  S.; Sharp, F.  R.  (1978)  Gasoline sniffing, lead  poisoning,  and myoclonus. J.  Am.
     Med.  Assoc. 240: 1375-1376.

Hansen, J.  C.; Christensen, L.  B. ;  Tarp,  U. (1980) Hair  lead concentration in children with
     minimal cerebral dysfunction. Dan. Med. Bull. 27: 259-262.

Harris, J. W.;  Greenberg, M.  S.  (1954)  Erythrocyte  fragilities in plumbism. Clin. Res.  Proc.
     2: 55.

Hart,  D.;  Graziano,  J.;  Piomelli,  S.  (1980)  Red  blood  cell  protoporphyrin  accumulation  in
     experimental lead poisoning.  Biochem. Med. 23: 167-178.

Harvey, P.; Hamlin, M.; Kumar, R.  (1983) The Birmingham blood  lead study. Presented at: annual
     conference of  the  British  Psychological Society, symposium on lead and health:  some psy-
     chological data;  April;  University of  York, United Kingdom. Available  for inspection  at:
     U. S.  Environmental  Protection  Agency,  Environmental  Criteria and  Assessment Office,
     Research Triangle Park, NC.

Harvey, P.  G. ;  Hamlin,  M.  W.;  Kumar,  R.; Delves,  H.  T.  (1984)  Blood  lead,  behaviour  and
     intelligence  test performance  in  preschool  children.  Sci.   Total  Environ.  40: 45-60.

Hasan,  J.;  Vihko,  V.;  Hernberg,  S.  (1967)  Deficient red cell  membrane  /Na  + K+/-ATPase  in
     lead poisoning. Arch.  Environ.  Health 14: 313-318.

Hass,  G.  M.;  Brown,  D.  V.  L. ;   Eisenstein,  R.;  Hemmens,  A. (1964) Relations  between lead
     poisoning in rabbit  and man.  Am. J. Pathol. 45: 691-727.

Hass,  G.  M. ;   McDonald, J.  H. ;  Oyasu,  R. ;  Battifora,  H.  A.;  Palouchek,  J.  T.  (1967)  Renal
     neoplasia  induced  by combinations of dietary lead subacetate and N-2-fluorenylacetamide.
     In:  King,  J.  S.,  Jr., ed.  Renal  neoplasia.  Boston, MA:  Little,  Brown and Company;  pp.
     377-412.

Hastings,  L.;  Cooper, G.  P.; Bornschein, R.  L.; Michaelson, I.  A. (1977) Behavioral effects of
     low level neonatal lead exposure. Pharmacol. Biochem. Behav. 7: 37-42.

Hastings,  L.;  Cooper,  G.  P.;  Bornschein, R.  L.;  Michaelson,   I. A. (1979)  Behavioral  deficits
     in adult rats following neonatal lead exposure. Neurobehav. Toxicol. 1: 227-231.

Hastings,   L. ;  Zenick,  H.;  Succop,  P.;  Sun, T. J.;  Sekeres,  R.  (1984)  Relationship between
     hematopoietic  parameters  and  behavioral  measures in  lead-exposed rats.   Toxicol.  Appl.
     Pharmacol. 73: 416-422.

Havelda,  C.  J.; Sohi,  G.  S.;  Richardson,  C.  E.  (1980) Evaluation of  lead, zinc, and copper
     excretion in chronic moonshine  drinkers. South. Med. J.  73: 710-715.


                                          12-320

-------
Hayashi, M.  (1983a) Lead  toxicity in the  pregnant  rat.  I. The effect  of high-level lead on
     6-aininolevulim'c  acid  dehydratase   activity  in  maternal  and  fetal  blood  or tissues.
     Environ. Res. 30:  152-160.

Hayashi, M.  (1983b)  Lead  toxicity  in  the pregnant  rat.  II.  Effects  of  low-level  lead on
     6-aminolevulinic  acid dehydratase  activity  in  maternal and  fetal  blood or tissue.  Ind.
     Health 21: 127-135.

Heck,  J.  D.;  Costa,  M.  (1982a)  In  vitro  assessment  of the  toxicity  of metal compounds: I.
     mammalian cell transformation. Biol. Trace Elem. Res.  4: 71-82.

Heck,  J.  D.;  Costa,  M.  (1982b)  In  vitro assessment of the  toxicity of metal compounds:  II.
     mutagenesis. Biol. Trace  Elem. Res.  4: 319-330.

Heddle,  J.  A.;  Bruce,  W.   R.  (1977)  Comparison of  tests  for mutagenicity  or  carcinogenicity
     using  assays  for  sperm abnormalities,  formation   of  micronuclei,  and  mutations in
     Salmonella.  In:   Hiatt,   H.  H.;  Watson,  J.   D. ;  Winsten,  J.  A.,   eds.  Origins of  human
     cancer.  Book  C:   Human  risk assessment.  Cold  Spring  Harbor,  NY:  Cold Spring  Harbor
     Laboratory;  pp.  1549-1557.  (Cold Spring  Harbor conferences on cell proliferation:  v.  4).

Hejtmancik, M.,  Jr.; Williams, B.  J.  (1977) Lead  (Pb)  exposure and norepinephrine (NE)  cardio-
     toxicity: participation of the vagus nerve.  Pharmacologist 19: 134.

Hejtmancik,  M. ,   Jr.;  Williams,  B. J.  (1978) Neonatal  lead (Pb)  exposure  and norepinephrine
     (NE) cardiotoxicity.  Pharmacologist 20:  263.

Hejtmancik,  M.  R.,  Jr.; Williams, B.  J.  (1979a)  Effect of  chronic lead exposure on the direct
     and indirect  components  of  the  cardiac   response   to  norepinephrine.  Toxicol.  Appl.
     Pharmacol.  51: 239-245.

Hejtmancik,  M.,   Jr.;  Williams,  B.  J.  (1979b) Time and  level of  perinatal  lead  exposure for
     development of norepinephrine cardiotoxicity.  Res.  Commun.  Chem.  Pathol.  Pharmacol.  24:
     367-376.

Hemphill,  F.  E.  ; Kaeberle, M. L.; Buck, W. B.  (1971)  Lead suppression of mouse resistance to
     Salmonella  typhimurium.  Science (Washington, DC)  172:  1031-1032.

Hench, P.  S.;  Vanzant, F.  R.;  Nomland, R. (1941) Basis for the early differential diagnosis of
     gout.  J.  Am. Med.  Assoc.  116: 217-229.

Henderson,  D.  A. (1954)  A follow-up of cases of plumbism  in children.  Australas. Ann.  Med. 3:
     219-224.

Henderson,  D.  A.;  Inglis,  J.  A.   (1957)  The  lead content  of bone  in chronic Bright's disease.
     Australas.  Ann.  Med.  6:   145-154.

Heptinstall, R.   H. (1974)  Pathology of  the  kidney.  2nd ed., v.  2.  Boston, MA: Little,  Brown
      and Company; pp.  1043-1122.

 Herber, R.  F.  M.  (1980)  Estimation  of blood  lead values  from   blood  porphyrin and  urinary
      5-aminolevulinic acid  levels in workers. Int. Arch.  Occup.   Environ.  Health  45:  169-179.
                                           12-321

-------
Herman, Z. S.;  Kmieciak-Kolada,  K. ;  Szkilnik, R.;  Brus,  R.;  Jonek, J.J.; Ludyga, K.; Winter,
     R. ;   Bodziony,  J. ;  Hebrowska,   B. ;  Kaminski,  K. ;  Piskorska,  D. ;  Wyrebowska,  J.  (1981)
     Chronic toxicity of lead and cadmium:  II. changes in the central nervous system of the Fa
     generation of  rats after  chronic intoxication with lead  and  cadmium.  Research Triangle
     Park,  NC:  U.  S.  Environmental  Protection  Agency;  EPA  report  no.  EPA-60071-81-013.
     Available from: NTIS, Springfield, VA; PB81-150989.

Hernberg, S. ;  Nikkanen, J.  (1970)  Enzyme  inhibition  by lead  under normal  urban conditions.
     Lancet 1(7637): 63-64.

Hernberg, S.; Nurminen,  M. ;  Hasan,  J. (1967a) Nonrandom shortening  of red cell survival times
     in men exposed to lead.  Environ. Res.  1: 247-261.

Hernberg, S. ; Veikko,  V.; Hasan, J.   (1967b)  Red cell  membrane  ATPases  in  workers exposed to
     inorganic lead. Arch. Environ.  Health 14: 319-324.

Hesley,  K.   L.; Wimbish,  G.  H.  (1981) Blood  lead and zinc  protoporphyrin in  lead industry
     workers. Am.  Ind. Hyg. Assoc. J. 42:  42-46.

Hiasa, Y.; Ohshima, M. ;  Yoshiteru,  K.; Fujita, T.; Yuasa, T.; Miyashiro, A. (1983) Basic  lead
     acetate: promoting effect on the development of renal tubular cell tumors in  rats treated
     with N-ethyl-N-hydroxyethylnitrosamine. J. Nat. Cancer Inst. 70: 761-765.

Hicks, R. M.  (1972) Air-borne lead as an environmental toxin: a review. Chem. Biol.  Interact.
     5: 361-390.

Hietanen, E. ; Kilpio,  J.;  Koivusaari, U.; Nevalainen,  T.;  Narhi,  M.; Savolainen, H.; Vainio,
     H. (1980) Neurotoxicity of lead in rabbits.  Dev. Toxicol. Environ. Sci. 8: 67-70.

Hilbelink, D. R.  (1980) Caudal  dysplasia:  an  animal  model  in the cadmium-lead treated golden
     hamster. Teratology 21:  44A.

Hilderbrand, D.  C.; Der, R.;  Griffin, W. T.; Fahim, M. S. (1973) Effect of lead acetate on re-
     production. Am. J. Obstet.  Gynecol. 115: 1058-1065.

Hill,  A.  B.  (1966)  Principles of medical  statistics.  8th Ed. New York, NY: Oxford University
     Press.

Hinton, D.  E.;  Heatfield,  B. M.; Lipsky,  M.  M. ; Trump, B. F.  (1980) Animal model: chemically
     induced renal tubular carcinoma in rats. Am. J. Pathol.  100: 317-320.

Hirsch,  G.   H.  (1973)  Effect  of  chronic   lead  treatment  on renal  function.  Toxicol.  Appl
     Pharmacol.  25:  84-93.

Hoffman, D.  J.;  Niyogi, S. K. (1977) Metal mutagens and carcinogens  affect RNA synthesis rates
     in a distinct manner. Science (Washington, DC) 198: 513-514.

Hoffmann, E.  0.;  Trejo, R.  A.;  Di  Luzio,  N. R.  ;  Lamberty,  J.  (1972) Ultrastructural altera-
     tions of liver and spleen following acute  lead administration  in rats. Exp.  Mol. Pathol
     17:  159-170.

Hoffmann, E.  0.;  Di  Luzio,  N.   R. ;  Holper,  K.;  Brettschneider,  L.; Coover, J.   (1974) Ultra-
     structural  changes  in the  liver  of baboons  following lead and endotoxin administration.
     Lab. Invest.  30:  311-319.

                                          12-322

-------
Hogstedt,  C.;  Hane,  M.;  Agrell,  A.;  Bodin,  L.  (1983)  Neuropsychological test  results and
     symptoms among workers with well-defined long-term exposure to lead. Br. J. Ind. Med. 40:
     99-105.

Hole, K.; Dahle, H.; Klove, H. (1979) Lead intoxication as an etiologic factor  in hyperkinetic
     behavior in children: a negative report. Acta Paediatr. Scand. 68: 759-760.

Holmes,  E.  W.;  Kelley, W.  N.  (1974)  Reevaluation of the  pyrazinamide  suppression test. In:
     Sperling,  0.; De  Vries,  A.;  Wyngaarden,  J. B. ;  eds.  Purine  metabolism  in  man:  bio-
     chemistry  and pharmacology  of  uric  acid  metabolism.  Proceedings  of the international
     symposium  on  purine  metabolism  in man;  June 1973; Tel  Aviv, Israel.  New York: Plenum
     Press; pp.  739-744.  (Advances in experimental medicine  and biology,  v.  41).

Holtzman,  D.;  Shen  Hsu,   J.  (1976)  Early  effects  of  inorganic  lead on  immature  rat  brain
     mitochondrial respiration. Pediatr. Res. 10:  70-75.

Holtzman, D.; Shen Hsu, J.; Mortell, P.  (1977) Effects of inorganic lead  on isolated rat  brain
     mitochondrial respiration. Pediatr. Res. 11:  407.

Holtzman,  D.; Shen Hsu, J.; Mortell, P. (1978)  In vitro effects  of inorganic  lead  on isolated
     rat brain mitochondrial  respiration.  Neurocfiim.  Res. 3: 195-206.

Holtzman,  D.;  Herman,  M.  M.;  Shen  Hsu,   J.;  Mortell, P.  (1980a) The  pathogenesis of  lead
     encephalopathy:  effects  of  lead  carbonate  feedings  on  morphology,   lead  content, and
     mitochondrial respiration  in brains of  immature  and adult rats. Virchows  Arch.  A:  Pathol.
     Anat. Histol. 387: 147-164.

Holtzman,  D. ; Obana,  K.;  Olson, J.  (1980b)  Ruthenium red  inhibition  of in vitro  lead effects
     on  brain mitochondrial  respiration. J.  Neurochem.  34:  1776-1778.

Holtzman,  D.;  Shen  Hsu,  J.;  Desautel, M.  (1981)  Absence of effects  of lead feedings and
     growth-retardation  on mitochondrial  and  microsomal  cytochromes  in  the developing brain.
     Toxicol. Appl. Pharmacol.  58:  48-56.

Hong,  C.  D.;  Hanenson, I.  G. ;  Lerner,  S.;  Hammond,  P.  B.;  Pesce, A.  J. ; Pollak,  V. E.  (1980)
     Occupational  exposure  to lead:  effects  on renal  function.  Kidney  Int.  18:  489-494.

Honma,  Y.;  Hozumi, M.;  Abe,  E.;  Konno,  K.; Fukushima,  M.;  Hata, S.;  Nishii, Y.; DeLuca, H.  F.;
     Suda,  T.  (1983) lce,25-dihydroxyvitanrin D3  and  lorhydroxyvitamin  D3 prolong survival time
     of mice  inoculated  with  myeloid leukemia cells.  Proc.   Natl.  Acad.  Sci.   U.S.A.  80:
     201-204.

Horiguchi,  S.;  Teramoto,  K.;  Nakano, H.; Shinagawa,  K.;  Endo, G.; Kiyota,  I. (1974) Osmotic
     fragility  test of red  blood  cells of  lead  workers  by coil  planet centrifuge. Osaka City
     Med.  J.  20:  51-53.

Hubermont,  G.;  Buchet, J.-P.;  Roels,  H.;  Lauwerys,  R. (1976)  Effect of short-term  administra-
     tion  of  lead to  pregnant rats.  Toxicology 5: 379-384.

Hunt,  T. J. ; Hepner,  R. ; Seaton,  K. W.  (1982)  Childhood lead poisoning and  inadequate child
     care.  Am.  J.  Dis.  Child.  136:  538-542.
                                           12-323

-------
Hunter, J.;  Urbanowicz, M.  A.;  Yule, W.;  Lansdown, R.  (1985)  Automated  testing of reaction
     time  and  its association with lead  in  children.  Int. Arch.  Occup.  Environ.  Health 57:
     27-34.

Ibrahim,  N.   G. ;   Hoffstein,  S.   T.;  Freedman,  M.   L.  (1979)  Induction of  liver  cell  haem
     oxygenase in iron-overloaded rats.  Biochem. J.  180: 257-263.

Imbus,  C.  E.;  Warner, J. ;  Smith,  E.;   Pegelow,  C.  H.;  Allen,  J.  P.;  Powars,  D.  R.  (1978)
     Peripheral neuropathy  in  lead-intoxicated sickle cell patients. Muscle Nerve 1: 168-171.

Impelman,  D. ;  Lear,  C.  L.;  Wilson, R. ;  Fox,  D.   A.  (1982)  Central   effects  of  low level
     developmental  lead  exposure  on  optic  nerve  conduction  and  the  recoverability  of
     geniculocortical responses in hooded rats. Soc.  Neurosci.  Abstr. 8: 81.

Inglis,  J.  A.;  Henderson,  D.  A.;  Emerson.  B.  T.  (1978)  The  pathology and  pathogenesis  of
     chronic lead nephropathy occurring in Queensland. J.  Pathol. 124: 65-76.

International  Agency  for Research on Cancer.  (1980) Lead and lead  compounds.  In:  IARC mono-
     graphs on the evaluation of the carcinogenic risk of chemicals to humans: some metals and
     metallic  compounds;  October  1979;  Lyon,  France.   Geneva,   Switzerland:   World  Health
     Organization/IARC; pp. 325-416. (IARC monographs on the carcinogenic risk of chemicals to
     humans:  v. 23).

Irwig,  L.  M. ;  Harrison, W.  0.; Rocks, P.; Webster,  I.; Andrew, M. (1978a) Lead and morbidity:
     a dose-response relationship. Lancet 2(8079): 4-7.

Irwig,  L.  M.;  Harrison, W. 0.; Webster,  L;  Andrew, M.  (1978b)  Lead and morbidity [letter].
     Lancet 2(8088):  533.

Ivanans, T.  (1975)  Effect of maternal education  and ethnic background  on infant development.
     Arch.  Dis. Child.  50: 454-457.

Ivanova-Chemishanska,  L.;  Antonov,  G. ;   Khinkova,  L.;  Volcheva,   VI.;  Khristeva,  V.  (1980)
     Deistvie  na  oloviniya  atsetat  v'Ykhu reproduktsiyata  na m"zhki  beli  pT'khove [Effect of
     lead acetate on reproduction in male white rats]. Khig. Zdraveopaz. 23: 304-308.

Jacquet, P.  (1976)  Effets du plomb administre durant la gestation a des souris C57B1 [Effects
     of lead administered during the gestation period of mice C57B1]. C. R. Seances Soc. Biol
     Ses Fil. 170: 1319-1322.

Jacquet, P.  (1977) Early  embryonic development in  lead-intoxicated  mice.  Arch.  Pathol.  Lab
     Med. 101: 641-643.

Jacquet, P. (1978) Influence de la progesterone et de Testradiol exogenes sur le processus de
     1'implantation embryonnaire, chez la souris femelle intoxiquee par  le plomb  [Influence of
     progesterone and exogenous estradiol on the process of embryonic implantation in a female
     mouse with lead intoxication].  C. R. Seances Soc. Biol. Ses Fil. 172: 1037-1040.

Jacquet, P. ;  Gerber,  G. B. (1979)  Teratogenic effects  of  lead  in  the  mouse.  Biomedicine 30-
     223-229.

Jacquet, P.;  Leonard,  A.; Gerber, G. B.  (1975) Embryonic death  in mouse due to lead exposure.
     Experientia 31:  24-25.


                                          12-324

-------
Jacquet, P.;  Leonard,  A.;  Gerber,  G. B. (1976) Action of lead on early divisions of the mouse
     embryo. Toxicology 6:  129-132.

Jacquet, P.;  Gerber,  G.  B.;  Maes,  J. (1977a) Biochemical studies in embryos after exposure of
     pregnant mice to dietary lead. Bull. Environ. Contam. Toxicol. 18: 271-277.

Jacquet, P.;  Gerber,  G.  B.;  Leonard, A.; Maes, J. (1977b) Plasma hormone levels in normal and
     lead-treated pregnant mice. Experientia 33: 1375-1377.

Jason,  K.  M.  ; Kellogg,  C. K.  (1980)  Behavioral  neurotoxicity  of lead.  In:  Singhal, P. L. ;
     Thomas,  J.  A.,  eds.  Lead toxicity.  Baltimore,  MD:  Urban  and Schwarzenberg,  Inc.; pp.
     241-271.

Jason, K. M. ; Kellogg, C.  K.  (1981) Neonatal lead  exposure: effects on development of  behavior
     and striatal dopamine neurons. Pharmacol. Biochem.  Behav. 15: 641-649.

Jeyaratnam, J.;  Devathasan,  G.;  Ong,   C.  N.;  Phoon, W.  0.;  Wong,  P.  K. (1985) Neurophysio-
     logical  studies on workers exposed to  lead.  Br. J.  Ind. Med. 42:  173-177.

Johnson,  D.   R.;  Kleinman,  L.   I.  (1979) Effects of lead  exposure  on  renal  function  in  young
     rats. Toxicol. Appl.  Pharmacol. 48:  361-367.

Johnson, B.  L. ;  Burg, J.  R.  ; Xintaras,  C.; Handke, J.  L.  (1980)  A  neurobehavioral examination
     of workers from a primary  nonferrous  smelter. Neurotoxicology  1:  561-581.

Johnstone,  R.  T.  (1964)  Clinical  inorganic   lead  intoxication.  Arch.  Environ.  Health  8:
     250-255.

Joselow,  M.  M.;  Flores,  J.  (1977)  Application  of  the  zinc  protoporphyrin  (ZP)  test as  a
     monitor  of occupational exposure to lead.  Am.  Ind.  Hyg. Assoc.  J. 38: 63-66.

Kadowaki,  S.  ;  Norman,  A.  W.  (1984a)  Dietary vitamin  D  is  essential for  normal  insulin
     secretion from the  perfused rat pancreas.  J.  Clin.  Invest.  73:  759-766.

Kadowaki,  S.; Norman, A.  W. (1984b) Pancreatic vitamin D-dependent calcium binding  protein:
     biochemical  properties  and response  to  vitamin  D.  Arch.  Biochem.  Biophys.  233:  228-236.

Kammholz,  L.  P.;  Thatcher,  L.  G.;  Blodgett, F.  M.; Good,  T.  A. (1972)  Rapid protoporphyrin
     quantisation for detection of lead poisoning. Pediatrics  50:  625-631.

Kang,  H.  K.; Infante,  P.  F.; Carra,  J. S.   (1980)  Occupational  lead  exposure and  cancer
      [letter]. Science (Washington,  DC) 207:  935-936.

Karai,  I.;  Fukumoto, K.;  Horiguchi,  S. (1981) Studies  on osmotic fragility  of red blood cells
      determined with  a coil  planet centrifuge for workers occupationally exposed to lead. Int.
     Arch.  Occup.  Environ. Health  48: 273-281.

Karp,  W. B. ; Robertson,  A.  F.  (1977)  Correlation of human placental enzymatic activity with
      trace  metal  concentration in placentas  from three geographical  locations.  Environ. Res.
      13:  470-477.

Kassenaar,  A.;  Morell, H.;  London,  I.  M.  (1957)  The  incorporation of glycine into globin and
      the synthesis of heme i_n vitro in  duck erythrocytes. J.  Biol. Chem. 229: 423-435.


                                           12-325

-------
Kaufman, A.  (1973) Gasoline sniffing among children in a Pueblo Indian village. Pediatrics 51:
     1060-1064.

Kawamoto, J. C.;  Overmann,  S.  R. ; Woolley,  D.  E. ;  Vijayan, V. K. (1984) Morphometric effects
     of preweam'ng  lead  exposure on the hippocampal  formation of adult rats. Neurotoxicology
     5: 125-148.

Kazantzis, G.  (1970) Industrial hazards to the kidney and urinary tract. In: Slater, J. D. H. ,
     ed. Sixth  symposium on advanced medicine: proceedings  of a conference held at the Royal
     College  of  Physicians of  London;  February;  London,  United  Kingdom.  London,  United
     Kingdom:  Pitman Medical & Scientific Publishing Co. Ltd.; pp. 263-274.

Kehoe,  R. A.  (1961a)  The metabolism of  lead in man in health and  disease:  the normal metab-
     olism  of  lead. (The  Harben lectures,  1960).  J.  R.  Inst. Public  Health  Hyg.  24: 81-97.

Kehoe,  R. A.  (1961b)  The metabolism of  lead in man in health and  disease:  the metabolism of
     lead under abnormal conditions.  (The  Harben  lectures, 1960).  J.  R.  Inst.  Public Health
     Hyg. 24:  129-143.

Kehoe,  R.  A.  (1961c)  The metabolism of lead  in  man in health  and  disease:  present hygienic
     problems  relating  to  the absorption  of  lead.  (The  Harben  lectures,  1960).  J.  R.  Inst
     Public Health Hyg. 24:  177-203.

Kendall,  R. J. ; Veit,  H. P.;  Scanlon,  P.  F. (1981) Histological effects  and lead concentra-
     tions  in tissues  of adult male ringed  turtle  doves  that ingested lead shot. J. Toxicol
     Environ.  Health 8: 649-658.

Kennedy, G.  L.;  Arnold, D. W.;  Calandra, J.  C.  (1975) Teratogenic evaluation of lead compounds
     in mice and rats.  Food Cosmet.  Toxicol. 13: 629-632.

Kerkvliet,  N.   I.;  Baecher-Steppan, L.  (1982)  Immunotoxicology  studies  on lead:  effects of
     exposure  on  tumor  growth  and cell-mediated tumor  immunity  after syngeneic or allogeneic
     stimulation. Immunopharmacology 4: 213-224.

Khan, M.  Y. ;  Buse,  M. ; Louria, D.  B.  (1977) Lead cardiomyopathy in  mice.  Arch.  Pathol.   Lab
     Med. 101:  89-94.

Khare, N. ;  Der,  R.; Ross, G.;  Fahim, M. (1978)  Prostatic cellular changes after injection of
     cadmium and  lead  into rat  prostate.  Res.  Commun.  Chem.  Pathol.  Pharmacol.  20:  351-365.

Khera,  A.  K.;  Wibberley,  D.  G.; Dathan,  J. G.  (1980) Placental  and  stillbirth tissue  lead
     concentrations in occupationally exposed women. Br. J.  Ind. Med. 37: 394-396.

Kihlstrdm, I.; Odenbro, A.  (1983) Effect of triethyl lead on the placental uptake and transfer
     of the non-metabolisable  craminoisobutyric acid in guinea pigs.  Toxicology 27: Ill-lie.

Kim C.  S. ; O'Tuama, L.  A.; Cookson,  S.  L.;  Mann, J.  D. (1980) The effects of lead poisoning on
     calcium transport  by  brain  in 30-day-old albino  rabbits,  Toxicol.  Appl.  Pharmacol. 52-
     491-496.

Kimmel,  C.  A.  (1984)  Critical  periods of  exposure and  developmental  effects  of  lead. In:
     Kacew,  S.;  Reasor,  M. J.,  eds.  Toxicology and the  newborn.  Amsterdam,  The Netherlands:
     Elsevier; pp. 219-235.


                                          12-326

-------
Kimrnel,  C.  A.;  Grant,  L.  D.;  Sloan,  C.  S.;   Gladen,  B.  C.  (1980)  Chronic  low-level  lead
     toxicity in the rat. Toxicol. Appl. Pharmacol. 56: 28-41.

Kincaid-Smith, P.  (1982)  Renal  pathology in hypertension and the effects of treatment. Br. J.
     Clin. Pharmacol. 13: 107-115.

Kirchgessner,  M.;  Reichlmayr-Lais,  A.  M.  (1981a)  Changes  of  iron  concentration  and iron-
     binding  capacity  in serum  resulting from  alimentary  lead  deficiency.  Biol. Trace Elem.
     Res. 3:  279-285.

Kirchgessner, M.; Reichlmayr-Lais, A. M. (1981b) Retention,  Absorbierbarkeit und  intermeditare
     Verftlgbarkeit von Eisen bei alimentarem Bleimangel  [Retention, absorbability and inter-
     mediate  availability  of iron with alimentary  lead deficiency].  Int. J. Vitam. Nutr. Res.
     51: 421-424.

Kirchgessner,  M.;  Reichlmayr-Lais,  A.  M.   (1982)  Konzentrationen verschiedener  Stoffwechsel-
     metaboliten  im experimentellen Bleimangel  [Concentrations of various  metabolites with
     experimental  lead deficiency].  Ann. Nutr.  Metab.  26:  50-55.

Kiremidjian-Schuiracher,  L.;   Stotzky, G.;  Dickstein,  R.  A.; Schwartz, J. (1981)  Influence  of
     cadmium,  lead,  and zinc  on  the  ability of  guinea  pig  macrophages to   interact with
     macrophage migration inhibitory factor.  Environ.  Res.  24:  106-116.

Kirkby,  H.;  Nielsen,  C.  0.; Nielsen, V.  K.; Gyntelberg,  F.' (1983)  Subjective symptoms  after
     long term  lead  exposure in  secondary  lead  smelting workers.  Br. J.  Ind. Med. 40:  314-317.

Kirkconnell,  S.  C.;  Hicks,  L.  E.  (1980)  Residual  effects of lead poisoning on Denver develop-
     mental  screening  test scores.  J. Abnorm. Child Psychol. 8:  257-267.

Kishi,  R.;   Ikeda,  T.; Miyake,  H.;  Uchino, E.; Tsuzuki,  T.;  Inoue, K.  (1983) Effects of  low
     lead exposure on neuro-behavioral function in the rat. Arch.  Environ.  Health 38:  25-33.

Klein,  A. W.;  Koch, T. ;  Lapinsky,  P.;  Schein, J.;  Moda,  L.  (1978) The  effects  of critical
     periods and low levels  of lead exposure on prenatal  rat brain morphology.  Anat.  Rec.  190:
     447.

Kline,  T. S.  (1960)  Myocardial  changes  in lead poisoning. Am. J.  Dis. Child.  99:  48-54.

Kobayashi,  N.;  Okamoto,  T.   (1974)  Effects of  lead  oxide on the induction of  lung  tumors in
     Syrian  hamsters.  J.  Natl.  Cancer Inst. (U.S.) 52: 1605-1610.

Kober,   T.  E.;  Cooper,  G.   P.  (1976)  Lead  competitively  inhibits  calcium-dependent synaptic
     transmission in the bullfrog sympathetic ganglion.  Nature (London)  262:  704-705.

Kohn,  K. W.;  Ewig, R.  A.  G. ; Erickson, L.  C.; Zwelling,  L. A.  (1981)  Measurement of strand
     breaks  and cross-links  by  alkaline elution.   In: Friedberg,  E. C.; Hanawalt, P. C., eds.
     DNA repair:  a  laboratory  manual  of  research procedures,  vol. 1,  part  B.  New York, NY:
     Marcel  Dekker;  pp.  379-401.

 Koinuma, S.  (1926) Impotence of workmen.  J. Am. Med.  Assoc. 86:  1924.

 Kolber, A.  R.; Krigman,  M.  R.;  Morell,  P. (1980)  The  effect  of  in  vitro  and ui vivo  lead
      intoxication on  monosaccharide transport  in  isolated rat  brain microvessels.  Brain  Res.
      192: 513-521.

                                            12-327

-------
Roller, L.  D.  (1973)  Immunosuppression produced  by  lead, cadmium, and  mercury.  Am.  J.  Vet.
     Res.  34:  1457-1458.

Koller, L.  D.;  Brauner,  J. A.  (1977)  Decreased B-lymphocyte  response  after  exposure to lead
     and cadmium.  Toxicol.  Appl. Pharmacol. 42: 621-624.

Koller, L. D.;  Kovacic, S.  (1974) Decreased antibody formation in mice exposed to  lead. Nature
     (London)  250: 148-150.

Koller, L. D. ;  Roan, J. G.  (1977) Effects of lead and cadmium on mouse peritoneal  macrophages.
     J. Reticuloendothel.  Soc. 21: 7-12.

Koller, L. D.;  Roan, J. G.  (1980a) Effects of  lead, cadmium and methylmercury on immunological
     memory. J.  Environ.  Pathol. Toxicol. 4:  47-52.

Koller, L.  D. ;  Roan,  J.  G.   (1980b)  Response  of lymphocytes  from  lead,  cadmium,  and methyl-
     mercury exposed  mice  in  the mixed  lymphocyte  culture.   J.  Environ.  Pathol.  Toxicol.  4-
     393-398.

Koller, L.  D. ;  Exon,  J.  H. ;  Roan, J.  G. (1976) Humoral antibody response  in mice  after single
     dose exposure to lead or cadmium.  Proc.  Soc. Exp. Biol. Med. 151: 339-342.

Koller, L.  D.;  Roan,  J.  G.;  Kerkvliet, N. I.  (1979) Mitogen stimulation  of lymphocytes in  CBA
     mice exposed to lead and cadmium.  Environ. Res. 19: 177-188.

Koller, L.  D. ;  Exon,  J.  H.;  Moore,  S. A.;  Watanabe,  P.  G.  (1983)  Evaluation  of ELISA  for
     detecting  i_n vivo  chemical  immunomodulation.  J.  Toxicol.   Environ.  Health  11:  15-22.

Keller, L.  D. ;  Kerkvliet,  N.  I.;  Exon,  J.  H.  (1985) Neoplasia  induced  in male rats  fed lead
     acetate ethyl urea and sodium mitrite. Toxicol. Pathol. 13: 50-57.

Kolton, L.; Yaari,  Y.  (1982) Sites of  action  of lead on  spontaneous  transmitter  release from
     motor nerve terminals. Isr. J. Med. Sci.  18: 165-170.

Konat, G. ;  Clausen,  J.  (1978) Protein composition of forebrain myelin  isolated from  triethyl-
     lead- intoxicated young rats. J. Neurochem. 30: 907-909.

Konat, G.; Clausen, J. (1980) Suppressive effect of triethyllead on entry of proteins  into  the
     CNS myelin sheath jin vitro. J. Neurochem. 35: 382-387.

Konat, G. ;  Offner,  H.; Clausen, J. (1978)  Effect of triethyllead on  protein  synthesis in  rat
     forebrain.  Exp. Neurol.  59: 162-167.

Konat,  G.;  Offner,  H. ;  Clausen,  J.  (1979) The  effect of  triethyllead  on  total and myelin
     protein synthesis in rat forebrain slices. J. Neurochem.  32:  187-190.

Kopp,  S.  J.;  Glonek,  T.;  Erlanger, M.;  Perry,  E.  F.; Perry, H.  M.,  Jr.; Barany, M.  (1980a)
     Cadmium and  lead  effects  on myocardial  function  and  metabolism.  J.  Environ.  Pathol
     Toxicol.  4: 205-227.

Kopp,  S.  J.; Barany,  M.;  Erlanger, M.;  Perry, E.  F.;  Perry,  H. M., Jr.  (1980b) The  influence
     of chronic  low-level  cadmium and/or  lead feeding  on myocardial  contractility  related to
     phosphorylation  of  cardiac  myofibrillar  proteins. Toxicol.  Appl.   Pharmacol. 54: 48-56.


                                           12-328

-------
Kosmider,  S.;  Petelenz,   T.   (1962)   Zmiany  elektrokardiograficzne  u  starszych  osob   z
     przewleklym zawodowym zatruciem olowiem [Electrocardiographic changes in elderly patients
     with chronic professional lead poisoning].  Pol. Arch. Med. Wewn. 32: 437442.

Kostas, J. ;  McFarland,  D.  J.; Drew, W. G. (1976) Lead-induced  hyperactivity: chronic exposure
     during the neonatal period in the rat. Pharmacology 14: 435-442.

Kostas, J.; McFarland, D. J.; Drew, W. G.  (1978) Lead-induced behavioral disorders  in the  rat:
     effects of amphetamine. Pharmacology  16:  226-236.

Kostial,  K.; Vouk,  V.  B. (1957)  Lead ions and synaptic transmission in the  superior cervical
     ganglion of the cat. Br. J.  Pharmacol. 12: 219-222.

Kotok,  D.  (1972) Development of  children with elevated blood  levels: a controlled study.  J.
     Pediatr. (St.  Louis) 80: 57-61.

Kotok,  D.;  Kotok,  R.;  Heriot, T.  (1977)  Cognitive evaluation  of  children with elevated blood
     lead  levels. Am. J. Dis. Child.  131:  791-793.

Kowalski,  S.;  Parker,  G. H.; Persinger,  M.  A. (1982)  Interactions  of 2-ppm lead in the water
     supply  with food  deprivation upon maze-swimming  behavior of mice. Percept.  Mot.  Skills
     55:  515-519.

Krasovskii,  G.  N.;  Vasukovich, L.  Y. ;  Chariev, 0. G.  (1979)  Experimental  study of biological
     effects of  lead and aluminum following  oral  administration. Environ.  Health Perspect. 30:
     47-51.

Krehbiel,  D. ;  Davis,  G. A.;  LeRoy,  L.  M. ; Bowman,  R.  E. (1976) Absence of hyperactivity  in
     lead-exposed developing  rats.  Environ.  Health Perspect.  18: 147-157.

Kremer,  H.  U.;  Frank,  M. N.  (1955) Coexisting myxedema and chronic plumbism.  Ann. Intern. Med.
     42:  1130-1136.

Krigman,  M. R.  (1978)  Neuropathology  of heavy metal  intoxication.  Environ.  Health Perspect.
     26:  117-120.

Krigman,  M. R.;  Druse, M.  J. ;  Traylor,  T.   D.;  Wilson,  M.  N.;  Newell,  L.  R.; Hogan, E.  L.
      (1974a)  Lead  encephalopathy   in   the  developing  rat:   effect  upon  myelination.   J.
      Neuropathol.  Exp.  Neurol.  33: 58-73.

 Krigman, M.  R.;  Druse, M.  J.;  Traylor,  T.   D.;  Wilson,  M.  N.;  Newell, L.  R.; Hogan,  E.  L.
      (1974b) Lead  encephalopathy in  the developing  rat: effect on cortical ontogenesis.  J.
      Neuropathol.  Exp.  Neurol.  33: 671-686.

 Krigman, M. R.; Traylor,  D.  T.; Hogan,  E.  L. ; Mushak, P. (1974c) Subcellular  distribution of
      lead in the brains of intoxicated and control rats.  J. Neuropathol. Exp.  Neurol.  33:  562.

 Kristensen, B.  0.  (1978)  Increased  serum levels of  immunoglobulins in untreated  and  treated
      essential   hypertension:   I.  relation  to blood  pressure.  Acta Med.  Scand.   203:  49-54.

 Kristensen, B.  0.; Andersen,  P.  L.  (1978) Autoantibodies  in  untreated and  treated  essential
      hypertension:  I.  Acta Med.  Scand. 203: 55-59.
                                            12-329

-------
Kuhnert, P. M.;  Erhard,  P.;  Kuhnert, B.  R.  (1977) Lead and 6-aminolevulinic acid dehydratase
     in RBC's of urban mothers and fetuses. Environ. Res. 14: 73-80.

Kurlander, H.  M.; Patten, B.  M. (1979) Metals in spinal cord tissue of patients dying of motor
     neuron disease. Ann. Neurol.  6: 21-24.

Kusell,  M.;   Lake,   L. ;  Andersson,  M.;  Gerschenson,   L.   E.   (1978)  Cellular  and  molecular
     toxicology of  lead: II.  effect of lead on 6-aminolevulinic  acid  synthetase of cultured
     cells. J. Toxicol. Environ. Health 4: 515-525.

Lamola, A.-A.; Joselow, M.; Yamane, T. (1975a) Zinc protoporphyrin (ZPP): a simple, sensitive,
     fluorometric  screening  test  for  lead  poisoning.  Clin.   Chem.  (Winston-Salem,  NC)  21:
     93-97.

Lamola,  A.-A.;  Piomelli,  S.;  Poh-Fitzpatrick,  M. B. ;  Yamane,  T.;  Harber,  L.  C.  (1975b)
     Erythropoietic  protoporphyria and  lead intoxication:  the  molecular basis for difference
     in  cutaneous   photosensitivity:  II.  different  binding of  erythrocyte  protoporphyrin to
     hemoglobin. J. Clin. Invest.  56: 1528-1535.

Lamon,  J.  M.;  Frykholm,  B.  C.; Tschudy,  D.  P.  (1979) Hematin  administration to  an adult with
     lead intoxication. Blood 53:  1007-1011.

Lampert,  P.  W.; Schochet,  S.  S.,  Jr.  (1968) Demyelination and remyelination in lead neuro-
     pathy: electron microscopic studies. J. Neuropathol. Exp.  Neurol. 27: 527-545.

Lancereaux,  E.  (1862)  Note  relative a  un cas  de paralysie   saturnine avec  alteration des
     cordons  nerveux et des  muscles paralyses  [Note  on a case  of  saturnine paralysis with
     alteration of  the paralyzed nerve funiculi and muscles]. Gaz. Med.  Paris: 709-713.

Lancranjan, I.; Popescu, H. I.; Gavanescu, 0.; Klepsch, I.; Serbanescu,  M. (1975) Reproductive
     ability  of workmen occupationally  exposed to  lead.  Arch.  Environ.  Health 30: 396-401.

Landaw, S. A.;  Schooley, J.  C.; Arroyo, F. L. (1973)  Decreased erythropoietin (ESF) synthesis
     and impaired erythropoiesis in  acutely lead-poisoned rats.  Clin. Res. 21: 559.

Landrigan,  P.  J.;  Gehlbach,  S.  H.;  Rosenblum,   B.  F.; Shoults,  J.  M.; Candelaria,  R.  M. •
     Barthel,  W.  F.;  Liddle,  J.  A.; Smrek,  A.   L.;  Staehling, N. W.;  Sanders, J.  F. (1975)
     Epidemic  lead  absorption  near an ore smelter:  the  role of particulate  lead. N. Engl. J.
     Med. 292: 123-129.

Landrigan, P.  J.;  Baker, E.  L., Jr.; Feldman,  R.  G.; Cox,  D.  H.; Eden, K.   V.;  Orenstein, W.
     A.;  Mather,  J. A.;  Yankel,  A.  J.;  von Lindern,  I. H.  (1976)  Increased lead absorption
     with anemia and slowed nerve conduction in children near a lead smelter. J.  Pediatr.  (St
     Louis) 89: 904-910.

Landrigan, P. J.; Baker, E. L., Jr.; Himmelstein, J. S.; Stein,  G. F.; Wedding,  J. P.; Straub,
     W. E.  (1982)  Exposure to  lead  from the Mystic River bridge:  the dilemma of deleading. N
     Engl. J. Med.   306: 673-676.

Lane,  R. E. (1949)  The care of the  lead worker. Br. J. Ind. Med. 6: 125-143.

Lane,  R.   E.  (1964)  Health control  in  inorganic lead  industries:   a  follow-up  of exposed
     workers. Arch. Environ. Health  8: 243-250.


                                          12-330

-------
Lansdown,  R.  G.;  Shepherd,  J. ;  Clayton,  B. E. ; Delves,  H.  T.;  Graham, P.  J.;  Turner,  W. C.
     (1974)   Blood-lead  levels,  behaviour,  and  intelligence:   a  population   study.  Lancet
     1(7857):  538-541.

Lansdown,  R. ;  Yule,  W.; Urbanowicz, M. A.; Hunter, J. (1986) The relationship between blood
     lead concentrations,   intelligence,   attainment  and  behaviour  in  a  school  population:
     the second London study. Int. Arch. Occup. Environ. Health 57: 225-235.

Lanthorn,  T.;  Isaacson, R.  L. (1978) Effects of chronic lead ingestion in adult  rats. Physiol.
     Psycho!.  6:  93-95.

Laughlin,  N.  K.;  Bowman,  R. E. ;  Levin,  E. D.; Bushnell,  P.  J.  (1983) Neurobehavioral conse-
     quences  of early  exposure to lead in  Rhesus monkeys: effects  on cognitive  behaviors.  In:
     Clarkson,  T.  W.;   Nordberg,  G. F.;   Sager,  P. R.,  eds.  Reproductive  and developmental
     toxicity of metals  [proceedings of a  joint meeting;  May 1982;  Rochester,  NY]. New York,
     NY: Plenum Press; pp.  497-515.

Lauwerys,  R. ; Buchet,  J.-P.;  Roels, H.  A.;  Materne,  D.  (1974)  Relationship between urinary
     6-aminolevulinic  acid  excretion  and the  inhibition  of   red cell   6-aminolevulinate
     dehydratase by lead. Clin.  Toxicol. 7: 383-388.

Lauwerys, R.; Buchet,  J.-P.;  Roels,  H.;  Hubermont,  G.  (1978)   Placental  transfer of lead,
     mercury,  cadmium, and  carbon monoxide in women.  I:  Comparison of the  frequency distri-
     butions  of the biological  indices  in  maternal  and  umbilical  cord blood.  Environ.  Res.  15:
     278-289.

Lawrence, D.  A.  (1981a) Heavy  metal modulation of lymphocyte activities:  I.  in vitro effects
     of  heavy  metals  on  primary  humoral immune  responses.  Toxicol.  Appl."T'harmacol.   57:
     439-451.

Lawrence,  D.  A.  (1981b)  Heavy  metal  modulation of  lymphocyte  activities  - II.  lead,  an  in
     vitro  mediator of B-cell  activation.  Int.  J.  Immunopharmacol.  3:  153-161.

Lawrence, D.  A.  (1981c)  Ir\ vivo and  HI  vitro effects  of  lead  on  humoral  and cell-mediated
     immunity. Infect.  Immun.  31:  136-143.

Leckie,  W.  J.  H.; Tompsett,  S.  L.  (1958) The diagnostic  and  therapeutic use of  edathamil
     calcium  disodium (EDTA,Versene)  in   excessive inorganic  lead absorption.  Q.  J.  Med.  27:
     65-82.

Ledda-Columbano,  G.  M.;  Columbano, A.;  Pani, P.  (1983) Lead and liver cell  proliferation:
     effect of  repeated  administrations.  Am. J.  Pathol. 113:  315-320.

Legge,  T. M.  (1901)  Industrial  lead poisoning.  J.  Hyg.  1:  96-108.

Leikin,  S. ; Eng,  G.  (1963)  Erythrokinetic studies of the anemia of lead poisoning.  Pediatrics
     31:  996-1002.

Lejeune,  E.;  Tolot,  F.;  Meunier,  P.  (1969)  Goutte  et  hyperuricemie au cours du saturnisme
     [Gout  and  hyperuricemia   in  lead  poisoning].   Rev.  Rhum.   Mai.   Osteo-Articulaires 36:
     161-173.
                                           12-331

-------
Leonard, A.; Linden,  G.;  Gerber,  G. B. (1973) Etude, chez la souris, des effets genetiques et
     cytogenetiques  d'une contamination  par  le  plomb  [Study  in  the  mouse  of  genetic and
     cytogenetic effects  of  lead  contamination].  In: Barth, D.; Berlin, A.; Engel, R.; Recht,
     P.; Smeets,  J., eds.  Environmental  health  aspects  of lead:  proceedings,  international
     symposium;  October  1972;  Amsterdam,  The  Netherlands.  Luxembourg:   Commission  of the
     European Communities; pp. 303-309.

Leonard, A.;  Deknudt, G. ;  Debackere,  M.   (1974)  Cytogenetic  investigations  on leucocytes of
     cattle intoxicated with heavy metals. Toxicology 2: 269-273.

Lerza,  P. ;  Fierro, 0. (1958) Contribution  to the x-ray study of  the gastro-intestinal  tract
     during lead poisoning.  Med.  Lavoro.  49: 789-810.

Levander, 0. A.;  Welsh,  S.  0.;  Morris, V.  C.  (1980) Erythrocyte deformability as affected by
     vitamin E deficiency and lead toxicity. Ann.  N.  Y.  Acad. Sci.  355: 227-239.

Levere,  R.  0.  ;  Granick,  S.  (1967) Control  of  hemoglobin synthesis  in  the  cultured  chick
     blastoderm.  J. Biol.  Chem.  242: 1903-1911.

Levi, D. S.; Curran,  A.  S. ; Alexander, S.  D.;  Davidow, B.; Piomelli, S. (1976) Physiological
     significance  of  erythrocyte  protoporphyrin  (EP)  in moderate  body  lead burden.  Pediatr
     Res. 10:  378.

Levin,  N.  W.;  Abrahams,  0.  L.  (1966)  Allopurinol  in patients  with  impaired renal  function.
     Ann. Rheum.  Dis. 25:  681-687.

Levin,  E. D.;  Bowman,  R.  E.  (1983) The effect of pre- or postnatal  lead exposure on Hamilton
     search task in monkeys. Neurobehav.  Toxicol.  Teratol.  5: 391-394.

Levitsky, D. A.;  Massaro,  T.  F. ;  Barnes, R.  H.  (1975)  Maternal malnutrition and  the neonatal
     environment. Fed. Pro.  Fed.  Am. Soc.  Exp. Biol.  34: 1583-1586.

Lewis,  B.  W.;  Collins,  R.  J.;  Wilson, H.  S.  (1955) Seasonal  incidence of  lead poisoning in
     children in St.  Louis.  South.  Med. J. 48: 298-301.

Lilienthal, H.  ;  Winneke,  G.;  Brockhaus,  A.; Molik,  B.;  Schlipkoter,  H.-W.  (1983)  Learning-set
     formation  in Rhesus  monkeys   pre-  and  postnatally  exposed  to  lead.  In:  International
     conference:   heavy  metals   in  the  environment;   September;   Heidelberg,  West  Germany.
     Edinburgh, United Kingdom:  CEP Consultants, Ltd.;  pp.  901-903.

Lilis,  R. (1981)  Long-term  occupational  lead exposure,  chronic nephropathy, and renal cancer:
     a case report. Am.  J. Ind.  Med. 2: 293-297.

Lilis,  R.;  Dumitriu,  C. ;  Roventa,  A.;  Nestorescu, B. ;  Pilat, L.   (1967)  Renal  function in
     chronic lead poisoning. Med.  Lav.  58: 506-512.

Lilis,  R.;  Gavrilescu,  N. ;  Nestorescu,  B.;  Dumitriu,  C.;  Roventa,  A.  (1968)  Nephropathy in
     chronic lead poisoning. Br.  J.  Ind.  Med.  25:  196-202.

Lilis,  R.;  Fischbein,  A.; Eisinger, J.;  Blumberg, W.  E.;  Diamond, S.;  Anderson,  H.  A.;  Rom,
     W.  ; Rice,  C.; Sarkozi,  L. ;  Kon,  S.;  Selikoff,  I. J.  (1977)  Prevalence  of  lead disease
     among  secondary lead smelter workers and biological indicators of lead exposure. Environ
     Res. 14:  255-285.


                                          12-332

-------
Lilis, R.; Eisinger, J.; Blumberg, W.; Fischbein, A.; Selikoff, I. J. (1978) Hemoglobin, serum
     iron,  and  zinc  protoporphyrin  in  lead-exposed workers.  Environ.  Health  Perspect.  25:
     97-102.

Lilis, R.;  Valciukas, J. ;  Fischbein,  A.;  Andrews,  G.; Selikoff,  I. J.;  Blumberg, W. (1979)
     Renal  function  impairment  in  secondary lead  smelter workers:  correlations  with  zinc
     protoporphyrin and blood lead levels. J. Environ. Pathol. Toxicol.  2: 1447-1474.

Lilis, R.;  Fischbein, A.; Valciukas, J. A.;  Blumberg, W.;  Selikoff,  I.  J. (1980)  Kidney func-
     tion  and lead:  relationships  in  several  occupational  groups with  different levels of
     exposure. Am. J. Ind. Med. 1: 405-412.

Lin-Fu, J.  S.  (1973) Vulnerability  of  children to lead exposure and toxicity:  parts one and
     two.   N. Engl. J. Med. 289:  1229-1233;  1289-1293.

Lindblad,  B.;  Lindstedt,  S.;  Steen, G.  (1977) On  the  enzymatic defects in  hereditary tyro-
     sinemia. Proc. Natl.  Acad. Sci. U.S.A.:  74: 4641-4645.

Linnane,  J. W.;  Burry,  A. F.;  Emmerson, B. T.  (1981) Urate deposits  in the  renal  medulla.
     Nephron 29:  216-222.

Litman,  D.  A.;  Correia,  M. A.  (1983)  L-tryptophan:  a common denominator of biochemical  and
      neurological  events  of acute  hepatic  porphyria? Science (Washington, DC) 222: 1031-1033.

Loch,  R.  K.; Rafales, L.  S.;  Michaelson, I. A.; Bornschein,  R.  L.  (1978) The  role of under-
      nutrition in animal  models of hyperactivity.  Life Sci. 22:  1963-1970.

Lockard,  R. B.  (1968)  The albino rat:  a defensible choice  or  a bad habit?  Am.  Psychol.  23:
      734-742.

Lockard,  R. B.   (1971)  Reflections on the  fall  of  comparative psychology: is there a message
      for  us all? Am.  Psychol.  26: 168-179.

Lorimer,  G.  (1886) Saturnine gout,  and its distinguishing marks.  Br.  Med.  J.  2(1334):  163.

Lower,  W.  R. ;  Thompson,  W.  A.;   Drobney,  V. K. ;  Yanders, A. F.  (1983) Mutagenicity  in the
      vicinity of a lead smelter.  Teratog. Carcinog. Mutagen. 3:  231-253.

Lucchi,  L.; Memo,  M. ;  Airaghi,  M.  L. ;  Spano,  P.  F.; Trabucchi, M.  (1981) Chronic  lead treat-
      ment induces in rat a specific and differential effect on dopamine receptors  in different
      brain areas. Brain Res.  213: 397-404.

 Ludwig,  G.  D. (1957) Saturnine gout: a secondary  type of gout. Arch.  Int. Med.  100: 802-812.

 Luster,   M.  I.;   Faith,  R.  E.; Kimmel,  C.   A.  (1978) Depression  of humoral  immunity in rats
      following chronic developmental  lead exposure. J. Environ.  Pathol.  Toxicol.  1:  397-402.

MacGee,  J.;  Roda,  S. M.  B.; Elias, S.  V.;  Lington,  E. A.; Tabor,  M. W.;  Hammond,  P.  B. (1977)
      Determination of  6-aminolevulinic  acid in blood plasma  and urine by gas-liquid chromato-
      graphy. Biochem. Med. 17: 31-44.

 Mahaffey-Six, K. ;  Goyer, R.  A.   (1972)  The  influence of  iron deficiency on  tissue content and
      toxicity of  ingested  lead in the rat.  J.  Lab.  Clin.  Med. 79:  128-136.


                                            12-333

-------
Mahaffey, K.  R. (1981) Nutritional factors in lead poisoning. Nutr. Rev. 39: 353-362.

Mahaffey, K.  R.  (1983)  Biotoxicity of lead:  influence of various factors. Fed. Proc. Fed. Am
     Soc. Exp.  Biol. 42: 1730-1734.

Mahaffey, K.  R.; Capar,  S.  G. ;  Gladen,  B.  C.;  Fowler,  B. A.  (1981)  Concurrent exposure to
     lead, cadmium, and arsenic.  J. Lab.  Clin.  Med. 98: 463-481.

Mahaffey, K.  R. ; Michaelson,  I.  A.   (1980)  The  interaction  between lead  and nutrition. In:
     Needleman,  H.  L.,  ed.   Low  level  lead exposure: the clinical implications  of current
     research.  New York, NY:  Raven Press; pp. 159-200.

Mahaffey, K.  R.; Rosen, J.  F. ;  Chesney,  R.  W. ;  Peeler,  J.  T.; Smith,  C. M. ;  De Luca,  H. F.
     (1982)  Association  between   age,  blood  lead concentration,  and  serum 1,25-dihydroxy-
     cholecalciferol levels  in children.  Am.  J. Clin. Nutr. 35: 1327-1331.

Mahaffey, K.  R.;  Smith, C. ;  Tanaka,  Y. ;  DeLuca,  H.  F. (1979)  Stimulation of  gastrointestinal
     lead absorption by 1,25-dihydroxyvitamin D3. Fed. Proc. Fed. Am. Soc. Exp. Biol. 38:  384.

Maines,  M. D. ;  Kappas,  A.  (1976) The induction of heme oxidation  in various  tissues by  trace
     metals:  evidence  for the catabolism of endogenous heme by  hepatic heme oxygenase.  Ann
     Clin. Res. 8 (suppl.  17): 39-46.

Maisin,  J.  R.;  Lambiet-Collier,  M. ;  De  Saint-Georges,  L. (1978)  Toxicite  du plomb pour les
     embryons  de la souris  [Lead toxicity for mouse embryos].  C.  R. Seances Soc.  Biol.  Ses
     Fil. 172:  1041-1043.

Makasev,  K.  K.;  Krivdina,  L. V.  (1972)   Status of the interstitial tissues  of vascular  walls
     and  their  penetration  under  lead  poisoning.  Tr.  Nauchno-Issled.   Inst.  Kraev.  Patol
     (Alma-Ata) 23: 11-13.

Maker, H. S.;  Lehrer,  G.  M.; Silides, D. J.  (1975) The effect  of  lead  on mouse brain develop-
     ment. Environ. Res. 10:  76-91.

Makotchenko,   V.   M.    (1965)  The  functional  condition  of  the  adrenal  cortex  in chronic
     poisoning  with  heavy  metals   (lead,  mercury).  Tr.  Ukr.  Nauch.  Issled   Inst.   Ekso
     Endokrinol. 20: 162-170.

Malcolm,  D.  (1971) Prevention of long-term  sequelae  following the absorption of lead.  Arch
     Environ. Health 23: 292-298.

Malpass,  C.  A., Jr.;  Asokan, S.  K.; Ulmer,  F.  T.   (1971)  Experimental lead  cardiomyopathy
     Circulation 44(suppl. 2): 11-104.

Mambeeva, A.  A.  (1963)  Motor-evacuatory function of  the  digestive tract during experimental
     lead intoxication. Byull. Eksper. Biol.  Med. 4: 41-44.

Mambeeva,  A.  A.;   Kobkova,  I.  D.  (1969)  Soderzhanie katekholaminov  v  tkanyakh  serdechno-
     sosudistoi  sistemy pri   eksperimentalnoi  svintsovoi   intoksikatsii  [The  concentration  of
     catecholamines  in  tissues of  the cardiovascular  system  in  experimental lead  intoxica-
     tion].   Izv. Akad.  Nauk  Kaz.  SSR. Ser. Biol.  1: 77-82.

Manalis,  R.  S. ;  Cooper, G.  P. (1973) Presynaptic and  postsynaptic  effects  of lead  at the frog
     neuromuscular junction.  Nature (London) 243: 354-356.

                                          12-334

-------
Manalis, R. S.;  Cooper,  G.  P.; Pomeroy, S.  L.  (1984) Effects of lead on neuromuscular trans-
     mission in the frog. Brain Res. 294: 95-109.

Mantere, P.; Hanninen,  H.;  Hernberg, S. (1982)  Subclinical  neurotoxic lead effects: two-year
     follow-up  studies  with   psychological  test  methods.   Neurobehav.  Toxicol.  Teratol.  4:
     725-727.

Manton, W.  I.; Cook,  J. D.  (1979) Lead content  of cerebrospinal  fluid  and  other tissue in
     amyotrophic lateral sclerosis  (ALS). Neurology 29: 611-612.

Mao,  P.;  Molnar, J.  J.  (1967)  The fine structure  and histochemistry  of lead-induced  renal
     tumors in rats. Am. J. Pathol.  50:  571-603.

Marecek, J.;  Shapiro,  I.  M. ; Burke,  A.;  Katz, S.  H.; Hediger,  M.  L.  (1983)  Low-level  lead
     exposure  in childhood influences  neuropsychological  performance.  Arch.  Environ. Health
     38: 355-359.

Marlowe,  M.;   Errera,  J.  (1982)   Low  lead  levels and  behavior problems  in  children. Behav.
     Disorders 7: 163-172.

Marlowe, M.;  Errera,  J.; Jacobs,  J.  (1983)  Increased lead  and  cadmium  burdens  among  mentally
     retarded  children  and children  with  borderline  intelligence.  Am. J. Ment. Defic.  87:
     477-483.

Marlowe, M.;  Folio, R. ; Hall, D.; Errera,  J. (1982)  Increased  lead burdens and trace-mineral
     status in mentally retarded  children. J.  Spec.  Ed.  16:  87-99.

Marlowe,  M.;  Stellern, J.;  Moon,  C.; Errera,  J.   (1985)  Main  and interaction effects of
     metallic  toxins  on aggressive classroom behavior.  Aggressive Behav.  11: 41-48.

Maxwell,  J.  D.;  Meyer, U. A.  (1976)  Effect of  lead  on  hepatic 6-aminolaevulinic acid syn-
      thetase   activity  in  the   rat:  a  model  for   drug  sensitivity in  intermittent  acute
     porphyria.  Eur.  J.  Clin.  Invest.  6: 373-379.

Mayers, M.  R.  (1947)  Industrial  exposure to  lead.  Occup.  Med.  3: 77-83.

Mayne,  J.  G.  (1955)  Pathological study of the  renal  lesions  found in 27  patients  with  gout.
      In:   American  Rheumatism  Association:   proceedings   of  the  second  interim  scientific
      session;  December; Bethesda, MD.  Ann.  Rheum.  Dis.  15:  61-62.

McAllister,  R. G., Jr.; Michelakis, A. M.;  Sandstead,  H.  H.  (1971)  Plasma renin activity in
      chronic  plumbism: effect of treatment.  Arch.  Intern.  Med. 127:  919-923.

McBride,  W. G.;  Black, B. P.;  English, B.   J.  (1982)  Blood lead levels  and  behaviour of 400
      preschool children. Med.  J.  Aust.  2:  26-29.

McCall, R.  B. ;  Hogarty,  P.  S.;  Hurlburt,  N.  (1972)  Transitions in  infant sensorimotor
      development and the prediction of childhood IQ. Am. Psychol. 27: 728-748.

 McCarren,  M. ; Eccles,  C.  U.  (1983) Neonatal lead exposure  in rats:  I. effects  on activity and
      brain metals.  Neurobehav. Toxicol. Teratol. 5:  527-531.

 McCauley,  P.  T.;  Bull, R.  J. (1978) Lead-induced delays in synaptogenesis in the rat cerebral
      cortex.  Fed. Proc. Fed.  Am.  Soc. Exp.  Biol. 37: 740.

                                           12-335

-------
McCauley,  P.  T. ;  Bull, R. J. ;  Lutkenhoff,  S.  D. (1979) Association  of alterations in energy
     metabolism with  lead-induced delays  in rat cerebral  cortical development. Neuropharma-
     cology 18: 93-101.

McCauley, P. T.; Bull, R. J.  ; Tonti, A. P.;  Lutkenhoff, S. D.; Meister, M. V.; Doerger, J.  U. ;
     Stober,  J.  A.  (1982)  The effect of  prenatal and  postnatal  lead  exposure  on  neonatal
     synaptogenesis in rat cerebal cortex. J. Toxicol. Environ. Health  10: 639-651.

McClain,  R.  M. ; Becker,  B.  A.  (1972) Effects  of  organolead compounds  on  rat embryonic  and
     fetal development. Toxicol. Appl. Pharmacol. 21: 265-274.

McClain, R. M.; Becker, B. A. (1975) Teratogenicity, fetal toxicity, and  placental  transfer of
     lead nitrate in rats. Toxicol. Appl.  Pharmacol. 31: 72-82.

McKay,  R.;  Druyan,  R.; Getz, G. S.;  Rabinowitz, M. (1969)  Intramitochondrial localization of
     6-aminolaevulate  synthetase and  ferrochelatase  in rat  liver.  Biochem.  J.  114:  455-461.

McKhann, C.  f.;  Vogt,  E. C.   (1926)  Lead  poisoning  in children: with notes on therapy. Am.  J
     Dis. Child. 32: 386-392.

McLean,  K.;  Parker,  G. H.;  Persinger, M.  A.  (1982) Lead in  the water  supply alters swimming-
     maze behavior in  adult  mice.  Percept. Mot.  Skills 55: 507-512.

McLellan, J.  S.;  VonSmolinski,  A.  W.; Bederka,  J.  P., Jr.;  Boulos, B.  M.  (1974) Developmental
     toxicology of lead in the mouse.  Fed. Proc. Fed. Am. Soc. Exp. Biol.  33: 288.

McMichael,  A.  J. ; Johnson,  H.  M.  (1982)  Long-term mortality profile of  heavily-exposed  lead
     smelter workers. J. Occup. Med. 24: 375-378.

McNeil,  J.  L.; Ptasnik, J.  A.  (1975)   Evaluation  of longterm effects  of elevated blood  lead
     concentrations  in asymptomatic  children.  In:  Recent  advances in  the  assessment of  the
     health  effects  of  environmental  pollution; v.  2.  proceedings, international  symposium,
     June  1974;  Paris,   France.   Luxembourg:  Commission  of  the  European   Communities;   pp.
     571-590.

McQueen, E. G. (1951)  The syndrome of  gout.  Med. J.  Aust. 1:  644-650.

Melberg,  P.-E.;  Ahlenius,   S.;  Engel, J. ;  Lundborg,  P.   (1976)  Ontogenetic  development  of
     locomotor  activity  and  rate  of  tyrosine  hydroxylation. Psychopharmacology 49:  119-123.

Mele,  P. C.;  Bushnell,  P.  J.;  Bowman,  R.  E.   (1984)  Prolonged behavioral  effects of early
     postnatal  lead exposure  in  rhesus  monkeys:   fixed-interval  responding  and  interactions
     with scopolamine  and pentobarbital. Neurobehav. Toxicol. Teratol.  6:  129-135.

Melgaard,  B.;  Clausen, J.;  Rastogi, S.  C.  (1976)  Electromyographic changes in automechanics
     with increased heavy metal  levels. Acta Neurol. Scand.  54: 227-240.

Mellins,  R.  B.;   Jenkins,   C.  D.  (1955)  Epidemiological   and   psychological   study  of  lead
     poisoning in children.  J. Am. Med. Assoc. 158:  15-20.

Memo,  M.;  Lucchi, L.;  Spano,  P.  F.;  Trabucchi, M.  (1980a) Lack  of correlation  between  the
     neurochemical  and  behavioural   effects induced  by d-amphetamine  in  chronically  lead-
     treated rats. Neuropharmacology 19: 795-799.


                                          12-336

-------
Memo, M.;  Lucchi,  L.;  Spano, P. F.; Trabucchi, M. (1980b) Effect of chronic lead treatment on
     gaba-ergic receptor function in rat brain.  Toxicol. Lett. 6: 427-432.

Memo, M.; Lucchi, L.; Spano, P. F.; Trabucchi, M. (1981) Dose-dependent and reversible effects
     of  lead on rat dopaminergic system. Life Sci. 28: 795-799.

Meredith,  P.  A.; Moore,  M.  R. (1979)  The influence of lead  on haem biosynthesis and biode-
     gradation in the rat. Biochem. Soc. Trans. 7: 637-639.

Meredith,  P.  A.;  Moore, M.  R.  (1980)  The  i_n vivo effects of  zinc on erythrocyte delta-amino-
     laevulinic acid dehydratase in man. Int. Arch.  Occup. Environ. Health 45:  163-168.

Meredith,  P.  A.;  Campbell, B.  C. ; Moore,  M.  R.;  Goldberg, A.  (1977)  The  effects of  industrial
     lead  poisoning on  cytochrome P450 mediated  phenazone (antipyrine) hydroxylation. Eur. J.
     Clin. Pharmacol. 12:  235-239.

Meredith,  P.  A.;  Moore, M.  R.; Campbell,  B.  C.; Thompson,  G.  G.;  Goldberg,  A. (1978) Delta-
     aminolaevulinic  acid metabolism  in  normal  and lead-exposed humans.  Toxicology 9:   1-9.

Michaelson,  I.  A.  (1973)  Effects of  inorganic  lead  on RNA,  DMA  and protein content in  the
     developing  neonatal  rat brain. Toxicol.  Appl. Pharmacol.  26: 539-548.

Michaelson,  I.  A.  (1980)  An appraisal  of rodent studies  on the behavioral toxicity  of  lead:
     the role of nutritional  status.  In:  Singhal,  R.  L.; Thomas,  J. A., eds.  Lead  toxicity.
     Baltimore,  MD: Urban  and Schwarzenberg,  Inc.; pp.  302-365.

Milar,  C.  R.; Schroeder,  S.  R.; Mushak,  P.;  Dolcourt,  J.  L.; Grant,  L.  D. (1980) Contributions
     of the  caregiving environment to  increased lead burden  of children.  Am.  J.  Ment.  Defic.
     84:  339-344.

Milar,  C.  R.; Schroeder,  S.  R.; Mushak,  P.;  Boone,  L.  (1981a) Failure to  find hyperactivity in
     preschool  children with moderately elevated lead burden.  J. Pediatr. Psychol.  6:  85-95.

Milar,  K.  S.; Krigman,  M.  R.;  Grant,  L.  D. (1981b)  Effects of neonatal  lead exposure on  memory
     in rats. Neurobehav.  Toxicol. Teratol.  3:  369-373.

Milburn, H. ; Mitran,  E.; Crockford,  G.   W.  (1976)  An investigation of  lead workers  for sub-
     clinical  effects  of lead using  three  performance  tests.  Ann.  Occup.  Hyg.  19:  239-249.

Millar, J. A.;  Cummings,  R.  L. C.;  Battistini, V.;  Carswell, F.; Goldberg, A.  (1970) Lead and
     6-aminolaevulinic  acid dehydratase  levels in mentally  retarded  children and  in  lead-
     poisoned suckling  rats. Lancet 2(7675):  695-698.

Miller, C. D. ;  Buck, W.  B. ; Hembrough, F.  B. ;  Cunningham,  W.  L. (1982) Fetal rat development
     as influenced by maternal lead exposure. Vet.   Hum. Toxicol. 24:  163-166.

Minsker, D.  H.;  Moskalski, N.; Peter, C.  P.; Robertson, R. T. ;  Bokelman, D. L. (1982) Exposure
     of rats to lead nitrate in utero or postpartum; effects  on morphology and behavior.  Biol.
     Neonate 41: 193-203.

 Missale,  C.;  Battaini, F.;  Govoni,  S.;  Castelletti,  L.;  Spano, P.  F.; Trabucchi, M.  (1984)
      Chronic lead  exposure  differentially  affects dopamine transport  in  rat  striatum and
      nucleus accumbens. Toxicology 33: 81-90.


                                           12-337

-------
Mistry, P.;  Lucier,  G.  W.;  Fowler, B. A. (1982) Characterization studies on the 63,000 dalton
     203Pb binding component  of rat kidney cytosol. In: 66th annual meeting of the Federation
     of American Societies  for Experimental Biology; April;  New Orleans,  LA.  Fed. Proc. Fed.
     Am.  Soc. Exp.  Biol. 41: 527.

Mitchell,  P.  R.;  Martin,   I.  L.  (1978)  Is GABA  release  modulated by  presynaptic receptors
     [letter]? Nature (London) 274: 904-905.

Mitchell,  R.  A.;  Drake, J.  E. ; Wittlin,  L.  A.;  Rejent,  T. A.  (1977)  Erythrocyte porphobi-
     linogen   synthase   (delta-aminolaevulinate   dehydratase)    activity:   a   reliable  and
     quantitative  indicator  of  lead  exposure  in humans. Clin.  Chem.  (Winston-Salem,  NC) 23:
     105-111.

Modak, A.  T.;  Purdy,  R. H.; Stavinoha, W. B.  (1978) Changes  in acetylcholine concentration in
     mouse brain following ingestion of lead acetate in drinking water. Drug Chem. Toxicol. 1:
     373-389.

Molina, G.;  Zuniga,  M.  A.;  Cardenas, A.  Alvarez,  R.  M. ; Solfs-Camara, P., Jr.; Solis-Camara,
     P. (1983)  Psychological  alterations in children exposed to a  lead-rich home  environment.
     Bull. Pan. Am. Health Org.  17: 186-192.

Molls, M.; Pon, A.;  Streffer, C.;  Van Beuningen, D. ; Zamboglou, N. (1983) The effects of lead
     and  X-rays,  alone  or in  combination,  on  blastocyst formation and  cell  kinetics  of pre-
     implantation mouse embryos  HI vitro. Int.  J. Radiat. Biol.  43: 57-69.

Monaenkova,  A.  M.  (1957)   K  voprosu  o  funktsionalnom sostoyanii shchitovidnoi  zhelezy pri
     chronicheskikh   intoksikatsiyakh   nokotorymi   promyshlennymi   yadami   (svinets   rtut)
     [Functional state  of the thyroid in chronic  intoxication  with some industrial poisons].
     Gig.  Tr. Prof. Zabol.  I:  44-48.

Moore, M.  R. ;  Beattie,  A.  D. ;  Thompson,  G.  G.;  Goldberg,   A.  (1971) Depression of 6-amino-
     laevulinic acid  dehydratase  activity  by  ethanol  in  man and  rat.  Clin.  Sci. 40:  81-88.

Moore, J.  F.; Goyer,  R.  A.;  Wilson, M. (1973) Lead-induced inclusion bodies: solubility, amino
     acid  content,  and relationship to  residual  acidic  nuclear proteins. Lab.  Invest.  29-
     488-494.

Moore, J.  F.; Mushak, P.; Krigman,  M. R. (1975a) Distribution of lead  in subcellular fractions
     of cerebrums of guinea pigs. Environ. Health Perspect. 10:  266-267.

Moore, M.  R.;  Meredith, P.  A.; Goldberg,  A.;  Carr,  K.  E.; Toner,  P.  G.; Lawrie,  T.  D.  V.
     (1975b)  Cardiac  effects  of lead  in drinking water  of rats. Clin.  Sci. Mol.  Med.  49:
     337-341.

Moore, M.  R. ; Meredith, P.  A.  (1976) The association  of  delta-aminolaevulinic  acid with the
     neurological   and  behavioural  effects  of  lead  exposure.  In:  Hemphill, D.  D. , ed. Trace
     substances in  environmental  health  -  X:   [proceedings  of  University  of  Missouri's 10th
     annual  conference  on  trace  substances  in  environmental   health];  June;  Columbia,  MO.
     Columbia, MO: University of Missouri-Columbia; pp. 363-371.

Moore, M.  R.;  Meredith, P.  A.;  Goldberg, A.  (1977) A  retrospective analysis  of blood-lead  in
     mentally retarded  children. Lancet 1(8014): 717-719.
                                          12-338

-------
Moore, M.  R.;  Meredith,  P.  A. (1979) The  effect of carbon monoxide upon erythrocyte 6-amino-
     levulim'cacid dehydratase activity. Arch. Environ. Health 34: 158-161.

Moore, M. R.; Meredith, P. A.; Goldberg, A. (1980) Lead and heme biosynthesis. In: Singhal, P.
     L. ; Thomas,  J.  A.,  eds.  Lead toxicity. Baltimore, MD: Urban and Schwarzenberg, Inc.; pp.
     79-118.

Morgan,  J.  M.  (1968) The consequences  of  chronic lead exposure. Ala. J. Med. Sci. 5: 454-457.

Morgan,  J.  M.   (1975)  Chelation therapy  in lead nephropathy.  South.  Med.  J.  68:  1001-1006.

Morgan,  J.  M.  (1976)  Hyperkalemia  and   acidosis  in lead  nephropathy.  South.  Med.  J.  69:
     881-886.

Morgan,  J.  M. ; Burch, H. B.  (1972) Comparative tests for diagnosis of lead poisoning. Arch.
     Intern. Med. 130: 335-340.

Morgan,  B.  B., Jr.; Repko, J.  D.  (1974)  Evaluation  of behavioral  functions  in workers  exposed
     to  lead.   In:  Xintaras,  C.;  Johnson, B. L.;  De Groot,  I.,  eds.   Behavioral  toxicology:
     early detection  of occupational  hazards.   Washington,  DC:  U.S.   Department  of  Health,
     Education  and  Welfare; pp.  248-266;  DHEW publication no.  (NIOSH)  74-126.

Morgan,  J.  M.;  Hartley,  M.  W.; Miller,   R.  E.  (1966) Nephropathy  in chronic lead  poisoning.
     Arch.  Intern.  Med.  118:  17-29.

Morris,  H.  P.; Laug,  E.  P.;  Morris,  H. J. ; Grant,  R.  L.  (1938) The growth and reproduction  of
      rats  fed  diets  containing lead  acetate and  arsenic trioxide and the lead  and  arsenic
      content of newborn  and suckling  rats. J.  Pharmacol.  Exp.  Ther.  64:  420-445.

Mouw,  D.  R.;  Vander, A.  J.; Cox, J.; Fleischer,   N.  (1978) Acute effects of  lead  on renal
      electrolyte excretion and  plasma  renin  activity. Toxicol. Appl.  Pharmacol.  46:  435-447.

Muir,  W. R. (1975)  A  review of studies  on the  effects of lead  smelter emissions in El Paso,
      Texas.  In:  International  conference  on  heavy metals in the  environment;  symposium  pro-
      ceedings:  volume  III;  October,  Toronto,  ON,  Canada. Toronto, ON,  Canada:  University  of
      Toronto,  Institute for Environmental Studies;  pp. 297-304.

Mukherji,  S. ;  Maitra, P.  (1976) Toxic effects of lead on growth and metabolism of germinating
      rice (Oryza sativa L.) seeds and mitosis of onion (Aliiurn cepa L.) root tip cells. Indian
      J.  ExpTBTol.  14: 519-521.

 Mullenix,   P.  (1980)  Effect  of lead on  spontaneous  behavior.  In:  Needleman,  H.  L.,  ed. Low
      level  lead  exposure:  the  clinical implications  of  current  research.  New York, NY:  Raven
      Press; pp. 211-220.

 Mtiller, S.;  Gillert, K.-E.; Krause,  C. ; Gross, U.;  L'Age-Stehr,  J. ;  Diamantstein, T. (1977)
      Suppression of delayed type hypersensitivity of mice  by lead.  Experientia 33:  667-668.

 Mungo,  A.;  Sessa,   G.  (1960) Radiological picture  of the digestive apparatus  in  occupational
      lead poisoning. Minerva Gastroenterol. 6:  163-171.

 Murakami, M.;  Hirosawa,  K. (1973)  Electron microscope autoradiography  of kidney after adminis-
      tration of  210Pb in mice.  Nature  (London)  245:  153-154.


                                            12-339

-------
Murashov, B.  F.  (1966)  Functional  state  of the adrenal cortex  in  chronic intoxication with
     tetraethyl lead. Gig.  Tr. Prof. Zabol. 10: 46-47.

Muro,  L.  A. ;  Goyer,  R.  A.   (1969)  Chromosome damage  in  experimental  lead  poisoning.  Arch
     Pathol. 87:  660-663.

Murray, R. E. (1939) Plumbism and chronic nephritis in young people  in Queensland. In: Service
     publication (School of  Public  Health and Tropical  Medicine):  number 2.  Glebe, New South
     Wales,  Australia:  Australasian Medical Publishing Company, Limited; pp. 1-81.

Murray,  H.  M.; Guruk,  M. ;  Zenick,  H.  (1978)  Effects of lead exposure  on  the developing rat
     parietal  cortex.  In:  Wahlum,  D.  D. ; Sikov, M.  R.; Hackett, P.  D.; Andrew,  F.  D., eds.
     Developmental  toxicology of energy-related pollutants.  Proceedings  of  the  17th annual
     Hanford biology symposium;  October  1977; Richland, WA; pp.  520-535.  U.S.  Department of
     Energy. (Symposium series v.  47).  Available  from:  NTIS, Springfield,  VA;  CONF-771017.

Myerson,  R.  M.;  Eisenhauer,  J.  H.  (1963)  Atrioventricular  conduction  defects   in  lead
     poisoning. Am. J.  Cardiol. 11:  409-412.

Mykkanen, H. M.;  Wasserman,  R. H.  (1982)  Effect of vitamin D on the  intestinal absorption of
     203Pb and 47Ca in chicks. J.  Nutr. 112:  520-527.

Mykkanen, H.  M. ;   Dickerson,  J.  W.   T.;  Lancaster,  M.  C.  (1979) Effect of age  on the tissue
     distribution of lead in the rat. Toxicol. Appl.  Pharmacol. 51:  447-454.

Mykka'nen, H. M.;  Dickerson,  J. W. T. ; Lancaster, M.  (1980) Strain differences in lead intoxi-
     cation in rats. Toxicol. Appl.  Pharmacol. 52: 414-421.

Mykkanen, H. M.;  Lancaster,  M. C.;   Dickerson, J. W.  T. (1982) Concentrations of lead in the
     soft tissues of male rats during a long-term dietary exposure.  Environ. Res. 28:  147-153.

Mylroie,  A.  A.;  Moore,  L.;  Olyai,   B.;  Anderson, M.  (1978)  Increased susceptibility to lead
     toxicity in rats fed semipurified diets.  Environ. Res. 15: 57-64.

Nation, J. R.; Clark, D. E. ; Bourgeois, A. E.; Rogers, J. K. (1982)  Conditioned suppression in
     the adult rat following chronic exposure  to lead. Toxicol. Lett.  14: 63-67.

National  Academy  of  Sciences. (1972)  Lead:  airborne  lead  in  perspective.  Washington, DC:
     National Academy of Sciences. (Biologic effects  of  atmospheric  pollutants).

National  Academy  of  Sciences, Committee on  Lead in the Human Environment. (1980) Lead  in the
     human environment. Washington,  DC: National Academy of Sciences.

Neal,  R.  A.  (1980) Metabolism of toxic  substances.  In:  Doull, J.;  Klaassen,  C. D.;  Amdur, M.
     0.,  eds.  Toxicology:  the basic science  of  poisons.  2nd  ed.  New York,  NY:   Macmillan
     Publishing Co., Inc.; pp. 56-69.

Neal,  P.  A.;  Dreessen, W.  C. ; Edwards,  T.  I.; Reinhart, W. H.;  Webster,  S.   H.; Castberg, H.
     T.;  Fairhall, L. T. (1941) A study of the effect of lead arsenate exposure on orchardists
     and  consumers  of  sprayed fruit. Washington, DC: Government  Printing Office; U.  S.  Public
     Health bulletin no. 267.
                                          12-340

-------
Nechay, B. R. ;  Saunders,  J.  P.  (1978a) Inhibitory characteristics of lead chloride in sodium-
     and potassium-dependent adenosinetriphosphatase  preparations derived from kidney, brain,
     and heart of several species. J. Toxicol. Environ. Health 4: 147-159.

Nechay, B. R. ; Saunders, J.  P.  (1978b) Inhibition by lead and cadmium of human Na , K  -ATPase
     activity. Toxicol. Appl .  Pharmacol. 45: 349.

Nechay,  B.   R. ;  Saunders,  J.  P.  (1978c)   Inhibitory  characteristics  of cadmium,  lead, and
     mercury  in  human  sodium  and potassium dependent  adenosinetriphosphatase preparations. J.
     Environ. Pathol. Toxicol.  2: 283-290.
Nechay,  B.   R. ;  Williams,  B.  J. ^197J)  Characteristics  of  sodium and  potassium dependent
     adenosine  triphosphatase  (Na  ,  K  -ATPase)  inhibition  by  lead.  In:   Brown,  S.  S. ,   ed.
     Clinical  chemistry  and  chemical  toxicology  of  metals.   New York,  NY:   Elsevier/North-
     Holland Biomedical Press; pp. 69-70.

Needleman,  H.  L.  (1982)  The  neurobehavioral consequences of  low lead exposure in  childhood.
     Neurobehav. Toxicol. Teratol. 4: 729-732.

Needleman,  H.  L. (1984) Comments  on chapter  12 and appendix  12C,  air quality criteria  for  lead
     (external  review draft  #1).  Available  for  inspection  at: U.S. Environmental  Protection
     Agency,  Central  Docket  Section,  Washington,  DC;  docket no. ECAO-CD-81-2II  A. E.C.I. 20.

Needleman,  H.  L. ;  Bellinger,  D.  (1984)  The developmental consequences of childhood  exposure to
     lead:  recent studies  and methodological  issues.   In:  Lahey, B. B. ;  Kazdin,  A.  E. ,  eds.
     Advances  in  clinical  child psychology:  v.  7.  New York, NY: Plenum Press; pp.  195-220.

Needleman,  H.  L. ;  Landrigan,  P.  J.  (1981) The health  effects of low level exposure  to  lead.
     Ann.  Rev.  Public Health  2:  277-298.

Needleman,  H.  L. ; Gunnoe, C. ;  Leviton,  A.;  Reed,  R. ;  Peresie, H. ; Maher,  C. ;  Barrett,  P.
     (1979) Deficits  in  psychologic  and  classroom   performance of children with  elevated
     dentine lead  levels.  N.  Engl .  J. Med. 300:  689-695.

Needleman,  H.  L.  ;  Leviton,  A.;  Bellinger, D.  (1982)  Lead-associated intellectual  deficit
     [letter].  N.  Engl.  J.  Med.  306:  367.

Needleman,  H.  L. ; Geiger,  S.  K. ; Frank,  R.  (1985)  Lead and IQ scores:  a  reanalysis [letter].
     Science (Washington, DC) 227:  701-704.

Neilan,  B.  A.; Taddeini,  L. ;  McJilton,  C.  E. ; Handwerger, B. S.  (1980)  Decreased T  cell
     function in mice exposed to chronic,  low levels of lead.  Clin.  Exp. Immunol.  39:  746-749.

Nelson,  D.  J. ;  Kiremidjian-Schumacher, L. ;  Stotzky,  G. (1982) Effects of cadmium, lead, and
     zinc on macrophage-mediated cytotoxicity  toward  tumor cells.  Environ.  Res.  28:  154-163.

Nestmann, E. R. ; Matula, T. I.; Douglas, G.  R. ; Bora,  K. C.  ;  Kowbel , D.  J. (1979) Detection of
      the mutagenic  activity  of lead chromate using a battery of microbial tests.  Mutat.  Res.
     66: 357-365.

Nicholls,  D.  G.  (1978) Calcium  transport  and proton electrochemical  potential  gradient in
     mitochondria from  guinea-pig cerebral  cortex  and rat  heart.   Biochem.  J. 170:  511-522.
                                           12-341

-------
Nicoll,  R.  A.  (1976) The  Interaction  of porphyrin  precursors with  GABA receptors  in the
     isolated frog spinal cord. Life Sci. 19:  521-525.

Nieburg, P. I.; Weiner, L. S.; Oski, B. F.; Oski, F. A. (1974) Red blood cell 6-aminolevulinic
     acid dehydrase activity.  Am. J. Dis. Child. 127: 348-350.

Nielsen, C. J.; Nielsen, V.  K.; Kirkby, H.; Gyntelberg, F. (1982) Absence of peripheral neuro-
     pathy in long-term lead-exposed subjects. Acta Neurol. Scand. 65: 241-247.

Niklowitz, W.  J.;  Mandybur,   T.  I.  (1975) Neurofibrillary  changes  following  childhood lead
     encephalopathy: case report. J. Neuropathol. Exp. Neurol. 34: 445-455.

Nishioka,  H.  (1975)  Mutagenic  activities of  metal  compounds  in  bacteria. Mutat.  Res. 31:
     185-189.

Nogaki, K. (1957) [On the action of lead on the body of lead  refinery workers: particularly on
     the conception,  pregnancy and parturition, in the case  of  females and  on the vitality of
     their newborn]. Igaku Kenkyu 27: 1314-1338.

Nordenson, I.;  Beckman,  G.;  Beckman, L.;  Nordstrom,  S.  (1978) Occupational and environmental
     risks in  and around a smelter in northern Sweden: IV. chromosomal aberrations  in workers
     exposed to lead. Hereditas 88: 263-267.

Nordstro'm, S.;  Beckman,  L.;  Nordenson,  I. (1978a) Occupational  and environmental risks  in and
     around a  smelter in northern Sweden: I.  variations  in birth weight. Hereditas  88: 43-46.

NordstrBm, S.;  Beckman,  L.;  Nordenson,  I. (1978b) Occupational  and environmental risks  in and
     around a  smelter 1n northern Sweden: III. frequencies of spontaneous abortion. Hereditas
     88: 51-54.

Nordstro'm, S.;  Beckman,  L.;  Nordenson,  I. (1979a) Occupational  and environmental risks  in and
     around a  smelter in northern Sweden: V.  spontaneous abortion among  female employees and
     decreased birth weight in their offspring. Hereditas  90: 291-296.

Nordstro'm, S.;  Beckman,  L.;  Nordenson,  I. (1979b) Occupational  and environmental risks  in and
     around a smelter in  northern Sweden:  VI.  congenital  malformations. Hereditas 90: 297-302.

Norton,  S.;  Culver, B.  (1977) A Golgi  analysis of caudate neurons  in  rats exposed to  carbon
     monoxide. Brain Res. 132: 455-465.

Nye,  L. J.  J.  (1933)  Chronic  nephritis and  lead  poisoning.  Sydney,  Australia:  Angus and
     Robertson, Ltd.

Odenbro, A.;  KihlstrBm,  J.  E. (1977)  Frequency of pregnancy and ova implantation  in triethyl
     lead-treated mice. Toxicol. Appl. Pharmacol.  39:  359-363.

Odenbro,  A.;  Orberg, J.; Lundqvist,  E.  (1982) Progesterone and oestrogen concentrations  in
     plasma  during  blastocyst implantation in  mice  exposed  to triethyl  lead. Acta Pharmacol.
     Toxicol. 50: 241-245.

Odenbro, A.;  Greenberg,  N.;  Vroegh, K.;  Bederka,  J.; Kihlstro'm, J.-E.  (1983)  Functional dis-
     turbances  in lead-exposed children.  Ambio  12: 40-44.
                                           12-342

-------
Odone, P.; Castoldi, M. R.;  Guercilena, S.; Alessio, L. (1979) Erythrocyte zinc protoporphyrin
     as  an  indicator  of  the biological  effect of  lead  in  adults  and children.  In:  Inter-
     national   conference:  management  and  control  of  heavy  metals  in  the  environment;
     September; London, United  Kingdom.  Edinburgh, United  Kingdom:  CEP  Consultants, Ltd.; pp
     66-69.

O'Flaherty,  E.  J. ;  Hammond,  P.  B. ;  Lerner,  S.  I.; Hanenson, I. B. ; Roda, S. M. B.  (1980) The
     renal  handling of  6-aminolevulinic  acid  in  the  rat and  in the  human.  Toxicol.  Appl.
     Pharmacol. 55: 423-432.

Ogilvie,  D. M. ;  Martin,  A.  H.  (1982) Aggression and open-field  activity of  lead-exposed mice.
     Arch. Environ. Contam.  Toxicol. 11:  249-252.

Ogryzlo,  M. A.;  Urowitz,  M.  B. ;  Weber,  H.  M.;  Houpt, J.  B.  (1966)  Effects of allopurinol on
     gouty and non-gouty  uric acid  nephropathy. Ann. Rheum.  Dis. 25: 673-680.

Ohnishi,  A.;   Dyck,  P. J.  (1981)  Retardation  of  Schwann  cell division  and axonal  regrowth
     following nerve crush in experimental  lead neuropathy.  Ann. Neurol. 10:  469-477.

Oliver,  T. (1885)  A clinical  lecture on  lead-poisoning. Br.  Med. J.  2(1294):  731-735.

Oliver,  T. (1891)  Lead poisoning  in its  acute and  chronic forms.  London, United Kingdom:  Young
     J.  Pentland.

Oliver,  T. (1911)  Lead poisoning  and the race.  Br. Med.  J.  1(2628):  1096-1098.

Ollivier, A.   (1863)  De   1'albuminurie  saturnine   [On  lead  albuminuria]. Arch. Gener. Med.  2:
      530-546,  708-724.

Olson,  L.; Bjorklund,  H.; Hoffer, B.;  Freedman, R.; Marwaha, J.; Palmer, M.; Seiger, A.  (1981)
      Silent  Purkinje neurons:  an effect of early chronic lead treatment on cerebellar grafts.
      Presented at:  meeting  on  chemical  indices  and  mechanisms  of  organ-directed toxicity;
      March; Barcelona, Spain.  Gen.  Pharmacol.  12:  A6.

Olson,   L.; Bjorklund, H. ;  Henschen, A.; Palmer,  M.;  Hoffer, B.  (1984) Some  toxic effects of
      lead,  other  metals  and antibacterial  agents on  the nervous  system  - animal experiment
      models.  Acta Neurol. Scand.  Suppl.  70: 77-87.

O'Riordan,  M.  L.; Evans,  H.  J.  (1974)  Absence of  significant chromosome damage in males occup-
      ational ly exposed to lead.  Nature (London) 247:  50-53.

Osheroff, M.   R.;  Uno, H.;  Bowman, R.  E.   (1982) Lead  inclusion bodies  in the anterior horn
      cells and  neurons   of  the  substantia  nigra  in  the adult rhesus  monkey.  Toxicol. Appl.
      Pharmacol. 64: 570-576.

 Oskarsson,  A.;  Squibb,  K.   S. ;  Fowler,  B. A.   (1982)  Intracellular binding of  lead  in the
      kidney:   the partial  isolation  and characterization  of  postmitochondrial  lead  binding
      components. Biochem. Biophys.  Res.  Commun. 104:  290-298.

 Ostberg, Y.  (1968)  Renal urate  deposits in chronic renal  insufficiency. Acta  Med.  Scand.  183:
      197-201.
                                            12-343

-------
Otto, D. A.  (1986)  The relationship of event-related  brain potentials and lead absorption: a
     review  of  current  evidence.   In: Wysocki,  L.;  Goldwater,  L.,  eds.  Lead environmental
     health:  the current issues:  in press.

Otto, D. A.;  Benignus, V. A.; Muller,  K.  E.;  Barton, C. N.  (1981) Effects of age and body lead
     burden  on  CMS  function  in  young  children.  I.  Slow cortical  potentials.  Electro-
     encephalogr.  Clin. Neurophysiol.  52:  229-239.

Otto, D. ;  Benignus,  V.; Muller,  K. ;   Barton,  C.; Seiple,  K.; Prah, J.;  Schroeder,  S.  (1982)
     Effects  of low  to moderate  lead exposure on slow cortical  potentials in young children:
     two year follow-up study. Neurobehav. Toxicol. Teratol. 4: 733-737.

Otto, D. ;  Robinson,  G.; Baumann,  S.; Schroeder,  S. ; Mushak,  P.;  Kleinbaum, D. ;  Boone,  L.
     (1985)  Five-year  follow-up   study  of  children  with  low-to-moderate  lead  absorption:
     electrophysiological evaluation.  Environ. Res.: 168-186.

Overmann,  S.  R.  (1977)  Behavioral effects  of  asymptomatic lead  exposure  during neonatal
     development in rats. Toxicol.  Appl.  Pharmacol. 41: 459-471.

Overmann,  S.  R.;  Fox,  D.  A.; Woolley,  D. E.  (1979)  Neurobehavioral   ontogeny of  neonatally
     lead-exposed rats. I.  Reflex development and somatic indices. Neurotoxicology 1: 125-147.

Overmann,  S.  R.;  Zimmer,  L.; Woolley,  D.  E.  (1981) Motor development,  tissue  weights and
     seizure  susceptibility   in  perinatally  lead-exposed   rats.   Neurotoxicology  2:  725-742.

Owen, G.; Lippman, G. (1977)  Nutritional  status of infants and young children:  U.S.A. Pediatr
     Clin.  North Am.  24: 211-227.

Oyasu,  R.; Battifora,  H.  A.; Clasen,   R.   A.;  McDonald, J.  H.; Mass, G. M.  (1970)  Induction of
     cerebral glioraas  in rats with dietary lead  subacetate and  2-acetylaminofluorene.  Cancer
     Res. 30: 1248-1261.

Padich,  R.;  Zenick,  H.  (1977) The  effects of developmental and/or direct  lead exposure on FR
     behavior in the rat. Pharmacol. Biochem.  Behav. 6: 371-375.

Paglia,   D.  E. ;  Valentine, W.  N.   (1975)  Characteristics of a pyrimidine-specific  5'-nucleo-
     tidase  in human erythrocytes.  J.  Biol. Chem.  250: 7973-7979.

Paglia,  D.  E.;  Valentine,  W. N.;  Dahlgren, J. G.  (1975) Effects of low-level  lead exposure on
     pyrimidine  5'-nucleotidase  and other erythrocyte  enzymes:  possible  role of  pyrimidine
     5'-nucleotidase  in  the  pathogenesis  of   lead-induced  anemia.   J.   Clin.   Invest.  56:
     1164-1169.

Paglia,   D.   E. ;  Valentine,   W.  N.; Fink,  K.  (1977)  Lead  poisoning:  further  observations  on
     erythrocyte   pyrimidine-nucleotidase  deficiency  and   intracellular  accumulation  of
     pyrimidine nucleotides.  J. Clin.  Invest.  60:  1362-1366.

Palmer,  M.  R.; Bjb'rklund, H.  ; Freedman, R.; Taylor, D. A.;  Marwaha, J. ; Olson,  L.; Seiger, A.;
     Hoffer,   B.  J.  (1981)  Permanent  impairment  of  spontaneous  Purkinje  cell  discharge in
     cerebellar grafts caused by chronic lead exposure. Toxicol.  Appl.   Pharmacol.  60: 431-440.

Palmer,   M.  R.;  Bjorklund, H. ;  Taylor, D.  A.; Seiger,  A.; Olson,  L.; Hoffer, B.  J.  (1984)
     Chronic  lead exposure  of the developing  brain:  electrophysiological  abnormalities of
     cerebellar Purkinje neurons.  Neurotoxicology 5: 149-166.

                                          12-344

-------
Panova, Z.  (1972)  Early  changes in the ovarian function of women in occupational contact with
     inorganic lead.  Works  of  the United Research Institute of Hygiene and Industrial Safety
     [Sofia, Bulgaria]:  161-166.

Pardo, V.;  Perez-Stable, E.; Fisher,  E.   R.  (1968) Ultrastructural  studies  in hypertension:
     III.  gouty nephropathy. Lab. Invest.  18: 143-150.

Parr, D.  R.;  Harris,  E.  J.   (1976) The  effect of lead on the calcium-handling capacity of rat
     heart mitochondria.  Biochem. J.  158:  289-294.
                t
Paul, C. (1860) Etude sur 1'intoxication lente par  les preparations de plomb, de son influence
     sur  le produit de  la   conception  [Study  of the effect of  slow  lead  intoxication on the
     product of conception]. Arch. Gen. Med. 15: 513-533.

Paulev, P.-E.;  Gry, C.;  Ddssing, M.  (1979) Motor  nerve  conduction  velocity in asymptomatic
     lead workers.  Int.  Arch. Occup.  Environ. Health 43: 37-43.

Pearl,  M.;  Boxt,   L. M.  (1980)  Radiographic findings  in congenital  lead poisoning. Radiology
     136:  83-84.

Pejic, S.  (1928) The nature  of  the primary  renal  lesion  produced by lead. Ann.  Intern. Med. 1:
     577-604.

Pentschew,  A. (1965) Morphology and  morphogenesis  of lead  encephalopathy. Acta  Neuropathol. 5:
     133-160.

Pentschew,  A.; Garro, F.  (1966) Lead encephalo-myelopathy  of the suckling rat and its  implica-
     tions  on  the porphyrinopathic  nervous diseases:  with special   reference  to  the  perme-
     ability  disorders  of   the nervous  system's  capillaries.  Acta  Neuropathol.  6:  266-278.

Penzien,  D.  B.;   Scott,  D.  R.   C.;  Motiff, J.  P.   (1982)  The effects  of  lead toxication on
      learning in  rats. Arch.  Environ.  Health 37:  85-87.

Perino,  J.; Ernhart,  C. B.  (1974)  The  relation  of  subclinical  lead  level to cognitive  and
      sensorimotor impairment in black  preschoolers. J.  Learn.  Dis.  7:  616-620.

Perlstein,  M.  A.;  Attala,  R.  (1966)  Neurologic  sequelae  of  plumbism  in  children.   Clin.
      Pediatr.  (Philadelphia) 5: 292-298.

Perry,  H.  M., Or.; Erlanger, M.  W.  (1978)  Pressor effects of chronically  feeding  cadmium and
      lead together. In:   Hemphill, D.  D., ed. Trace substances  in  environmental health  - XII:
      [proceedings  of University of Missouri's  12th annual conference  on  trace  substances in
      environmental health]; June; Columbia,  MO.  Columbia MO:  University of Missouri-Columbia;
      pp.  268-275.

Perry,  H.  M. ;  Erlanger, M. ;  Perry, E.  F.  (1979)  Increase in the systolic pressure of rats
      chronically  fed  cadmium.  Environ.  Health Perspect.  28: 251-260.
                                                                                       o
Persson,  H.  E.;  Knave,   B.;  Goldberg, J.  M.;  Johansson,  B.;  Holmqvist,  I.  (1979)  Langvarig
      exposition fb'r bly; III.  en neurologisk och neurofysiologisk undersbkning av personal vid
      Ronnskarsverken,  Boliden   AB   [Protracted  exposure  to  lead;   III.   a  neurological  and
      neurophysiological  study  of  personnel  at the Ronnskars Works:  Boliden, Inc.]. Arbete Och
      Halsa 1:  1-28.


                                           12-345

-------
Petit,  T.   L.;  Alfano,  D.  P.  (1979)  Differential  experience  following  developmental  lead
     exposure:  effects on brain and behavior.  Pharmacol. Biochem. Behav. 11: 165-171.

Petit,  T.  L. ;  LeBoutillier,  J.  C.  (1979)  Effects  of  lead  exposure during  development on
     neocortical dendritic and synaptic structure. Exp. Neurol. 64: 482-492.

Petit,  T.   L.;  Alfano,  D.  P.;  LeBoutillier,   J.   C.  (1983)  Early  lead  exposure  and  the
     hippocampus:  a review and recent advances.  Neurotoxicology 4: 79-94.

Petrusz, P.; Weaver, C. M.; Grant, L. D.; Mushak, P.; Krigman, M. R. (1979) Lead poisoning and
     reproduction:   effects  on pituitary  and  serum  gonadotropins in  neonatal  rats.  Environ.
     Res.  19: 383-391.

Pickett,  J.  B. ;  Bornstein,  J.  C.  (1984) Some effects  of  lead  at  mammalian neuromusclar
     junction.  Am.  J.  Physiol. 246: C271-C276.

Pienta, R. J.  (1980)  A transformation  bioassay  employing cryopreserved hamster embryo cells.
     In: Mishra, N. ;  Dunkel,  V.; Mehlman, M. , eds.  Mammalian cell transformation by chemical
     carcinogens.  Princeton Junction,  NJ:  Senate Press,  Inc.;  pp.  47-83.  (Advances in modern
     environmental  toxicology: volume I).

Pihl,  R.  0;  Parkes,  M.  (1977)  Hair element content  in  learning  disabled children.  Science
     (Washington,  DC) 198:  204-206.

Pines,  A. G.  (1965) Sostoyanie nekotorykh pokazatelei  obschchei  reaktivnosti pri svintsovykh
     intoksikatsiyakh  [Indexes  of  general  reactivity  in  saturnine  toxicity].  Vroch. Delo. 3:
     93-96.

Piomelli, S.  ; Graziano, J.  (1980)  Laboratory diagnosis  of lead poisoning.  Pediatr. Clin. North
     Am. 27:  843-853.

Piomelli, S. ;  Davidow,  B. ;  Guinee, V.  F. ; Young, P.; Gay, G.  (1973) The FEP  (free erythrocyte
     porphyrins) test:  a screening  micromethod   for  lead poisoning.  Pediatrics 51: 254-259.

Piomelli, S.;  Seaman, C.;  Zullow, D.;  Curran,  A.; Davidow,  B.  (1977) Metabolic evidence of
     lead toxicity  in "normal" urban children.  Clin. Res.  25: 459A.

Piomelli, S.; Seaman, C.; Zullow,  D.; Curran, A.; Davidow, B.  (1982) Threshold  for lead damage
     to heme synthesis in urban children. Proc.   Natl. Acad.  Sci.  U.S.A. 79: 3335-3339.

Piper,  W. N.;  Tephly, T. R.  (1974) Differential  inhibition  of erythrocyte and  hepatic uropor-
     phyrinogen I synthetase  activity by lead.  Life Sci.  14: 873-876.

Piper,  W. N.;  van  Lier, R. B. L.  (1977) Pteridine regulation  of  inhibition of  hepatic uropor-
     phyrinogen I synthetase  activity by lead chloride. Mol. Pharmacol. 13: 1126-1135.

Plechaty, M.  M.;  Noll, B.;  Sunderman,  F.  W.,  Jr.   (1977)  Lead concentrations  in semen of
     healthy  men  without  occupational  exposure to  lead.   Ann.  Clin. Lab.  Sci.  7:  515-518.

Pocock, S. J.;  Ashby, D. (1985) Environmental lead and children's  intelligence:  a review of
     recent  epidemiological studies. Statistician: in  press. Available for inspection  at:  U.S.
     Environmental  Protection Agency,  Environmental  Criteria  and Assessment Office,  Research
     Triangle Park, NC.


                                          12-346

-------
Poirier, L. A.;  Theiss,  J.  C.;  Arnold, L. J. ;  Shimkin,  M.  B. (1984)  Inhibition  by magnesium
     and calcium acetates of lead subacetate- and nickel  acetate-induced lung tumors in strain
     A mice.  Cancer Res.  44: 1520-1522.

Popoff, N. ;  Weinberg,  S.;  Feigin,  I.  (1963) Pathologic observations  in lead encephalopathy:
     with special reference to the vascular changes. Neurology 13: 101-112.

Porritt, N.  (1931) Cumulative  effects of infinitesimal  doses of lead.  Br.  Med.  J. 2(3680):
     92-94.

Pounds, J.  G.;  Mittelstaedt, R.  A.  (1983) Mobilization of  cellular calcium-45 and lead-210:
     effect of physiological stimuli.  Science (Washington, DC) 220;  308-310.

Pounds, J.  G.;  Wright,  R.; Morrison, D.; Casciano,  D.  A.  (1982a)  Effect of lead on calcium
     homeostasis in the isolated rat hepatocyte. Toxicol. Appl. Pharmacol.  63: 389-401.

Pounds,  J.  G.;  Wright,   R. ;  Kodell,  R.   L.  (1982b) Cellular  metabolism  of  lead:  a kinetic
     analysis  in the isolated rat hepatocyte. Toxicol. Appl.  Pharmacol.  66: 88-101.

Prasher,  D.  K.; Sainz,  M.; Gibson,  W.  P. R.  (1981) Binaural  voltage summation of brainstem
     auditory  evoked potentials: an  adjunct to  the  diagnostic criteria for multiple  sclerosis.
     Ann. Neurol.  11: 86-91.

Prendergast,  W.  D. (1910)  The  classification of the symptoms  of lead poisoning.  Br. Med.  J.
     1(2576):  1164-1166.

Prerovska,  I.  (1973) Einfluss von  Blei  auf  biochemische VerSnderungen  im Serum  und Verander-
     ungen  in der  Aderwand im Hinblick  auf  Atherosklerose  [Influence of  lead on  biochemical
     changes  in  serum and changes in the  arteries with  regard to  arteriosclerosis].  In:  Barth,
     D.;  Berlin, A.; Engel,  R.;  Recht,   P.;  Smeets,  J.,  eds. Environmental  health  aspects  of
     lead:  proceedings,   international symposium;  October  1972;  Amsterdam,  The  Netherlands.
     Luxembourg: Commission of  the  European  Communities,  pp.  551-558.

Press,  M.  F.  (1977)  Lead encephalopathy  in neonatal Long-Evans  rats: morphological  studies.  J.
     Neuropathol.  Exp. Neurol.  34:  169-193.

Prigge, E.;  Greve, J.   (1977)  Effekte   einer  Bleiinhalation  allein und  in  Kombination  mit
     Kohlenmonoxid bei   nichttragenden und tragenden Ratten und deren  Feten:  II.  Effekte  auf
     die  Aktivitat  der  6-Aminolavulinsaure-Dehydratase,  den Hamatpkrit  und  das  Korpergewicht
      [Effects of  lead  inhalation exposures  alone  and  in combination with carbon  monoxide in
      nonpregnant  and  pregnant  rats  and  fetuses:   II.   effects  on  6-aminolevulinic  acid
      dehydratase  activity,  hematocrit  and   body weight].  Zentralbl.  Bakteriol.  Parasitenkd.
      Infektionskr.  Hyg.  Abt.  1:  Orig.  Reihe  B 165:  294-304.

 Provvedini,  D.  M. ;  Tsoukas,  C.  D.;  Deftos,  L.  J.; Manolagas,  S.   C.  (1983) 1,25-dihydroxy-
      vitamin D3 receptors in  human  leukocytes.  Science  (Washington,  DC) 221:  1181-1182.

 Pueschel,  S.   M.;  Kopito, L.;  Schwachman, H. (1972)  Children with  an increased lead burden: a
      screening and follow-up  study.  J. Am. Med. Assoc.  222:  462-466.

 Puhac, I.;  Hrgovic,  N.; Stankovic,  M.;  Popovic,   S. (1963)  [Laboratory investigations  of  the
      possibility of application  of lead nitrates  compounds  as  a raticide means by decreasing
      reproductive capability of rats]. Acta Vet. (Belgrade)  13:  3-9.


                                           12-347

-------
Purdy,  S.  E.;  Blair,  J.  A.;  Leeming, R. J.;  Hilburn,  M.  E. (1981)  Effect  of lead on tetra-
     hydrobiopterin  synthesis  and  salvage:   a  cause  of  neurological  dysfunction.  Int.  J.
     Environ.  Stud. 17: 141-145.

Qazi, Q. H.; Go, S. C.; Smithwick, E. M.; Madahar, D. P. (1972) Osmotic resistance of abnormal
     red cells exposed to lead jui vitro. Br. J. Hematol. 23: 631-633.

Qazi, Q. H. ; Madahar, C.; Yuceoglu, A. M.  (1980) Temporary  increase  in chromosome breakage in
     an infant prenatally exposed to lead.  Hum. Genet. 53: 201-203.

Rabe, A.;  French, J.  H.;  Sinha,  B.;  Fersko, R.  (1985) Functional  consequences of prenatal
     exposure to lead  in immature rats. Neurotoxicology  6: 43-54.

Rabinowitz, M.  B.;  Leviton,  A.; Needleman, H. L. (1986) Occurrence of elevated protoporphyrin
     levels in relation to lead burden in infants. Environ.  Res.  39:  253-257.

Radosevic, Z. ;  Saric, M. ;  Beritic, T.;  Knezevic, J.  (1961) The  kidney in lead poisoning. Br.
     J.  Ind. Med. 18:  222-230.

Radulescu, I.  C.;  Dinischiotu,  G. T.; Maugsch,  C. ;  lonescu, C.; Teodorescu-Exarcu,  I. (1957)
     Recherches  sur  1'atteinte  du rein dans  le saturnisme  industriel par  1'etude du  clearance
     de  la creatinine et de Turee  [Research  on  damage  to  the kidney in industrial   lead
     poisoning  through the  study of  creatinine  and urine  clearance].  Arch.  Mai.  Prof. 18:
     125-137.

Rafales, L. S.;  Bornschein,  R.  L.;  Michaelson,  I.  A.;   Loch, R.  K.;  Barker,  G. F.  (1979) Drug
     induced activity  in lead-exposed mice. Pharmacol. Biochem. Behav. 10: 95-104.

Raghavan,  S. R. V.; Culver, B. D.; Gonick,  H.  C.  (1981)  Erythrocyte  lead-bindjng  protein  after
     occupational  exposure.  II.  Influence  on  lead  inhibition  of membrane Na  , K  -adenosine-
     triphosphatase.  J. Toxicol. Environ. Health  7:  561-568.

Ramel,  C.  (1973)  The effect of  metal  compounds on chromosome  segregation.  Mutat.  Res. 21:
     45-46.

Ramirez-Cervantes, B.; Embree, J. W.; Mine, C. H.; Nelson,  K. W.; Varner,  M.  0.;  Putnam,  R. D.
     (1978) Health assessment of employees  with different body  burdens of  lead. J.  Occup.  Med.
     20: 610-617.

Ramsay,  L. E.   (1979) Hyperuricaemia  in  hypertension:   role of alcohol.  Br. Med. J. 1(6164):
     653-654.

Rasmussen,  H.; Waisman,  D.  M.  (1983)  Modulation of cell  function  in  the  calcium  messenger
     system. Rev.  Physio!. Biochem.  Pharmacol. 95: 111-148.

Rate!iffe,  J.   M.  (1977) Developmental  and behavioural  functions  in  young  children  with
     elevated  blood  lead  levels. Br. J.  Prev.  Soc. Med.  31:  258-264.

Reddy,  T.  P.; Vaidyanath, K.  (1978) Synergistic interaction of  gamma rays and  some metallic
     salts in  the  induction of chlorophyll  mutations  in  rice. Mutat.  Res.  52:  361-365.

Refowitz,  R.  M.  (1984) Thyroid  function and  lead:   no clear relationship.  J. Occup. Med.  26:
     579-583.


                                          12-348

-------
Reichenbach, T.  (1979)  Untersuchungen zur  Frage  subklinischer neurogener  Schadigungen bei
     Personen  mit  beruflicher  chronischer  Exposition  gegenuber  Blei   und gegeniiber  Tri-
     chlorathylen [Investigations on  the  question of subclinical neurogenic damage in persons
     with  chronic  occupational  exposure  to  lead and  to  trichlorethylene] [dissertation].
     Erlangen-Nurnberg, West Germany:  Friedrich Alexander Universitat.

Reichlmayr-Lais, A. M. ;  Kirchgessner, M.  (1981a) Zur Essentialitat von Blei  fur das tierische
     Wachstum  [Why  lead  is  essential  for  animal   growth].   Z.  Tierphysiol.  Tierernaehr.
     Futtermittelkd. 46:  1-8.

Reichlmayr-Lais, A. M. ;  Kirchgessner, M.  (1981b) Depletionsstudien zur Essentialitat von Blei
     an wachsenden  Ratten [Depletion studies  on  the  essentiality of  lead in growing rats].
     Arch. Tierenaehr. 31: 731-737.

Reichlmayr-Lais,  A.  M. ;  Kirchgessner, M.  (1981c) Katalase- und  Coeruloplasmin-activitat  im
     Blut  bzw.  Serum  von  Ratten im  Blei-Mangel  [Catalase  and  ceruloplasmin activity in the
     blood  and serum  of rats with  lead deficiency].  Zentralbl.  Veterinaermed.  Reihe  A 28:
     410-414.

Reichlmayr-Lais,  A.   M.;   Kirchgessner,   M.  (1981d)   Eisen-,  Kupfer-   und Zinkgehalte   in
     Neugeborenen sowie  in Leber und  Milz wachsender Ratten  bei  alimentarem Blei-Mangel [Iron,
     copper  and  zinc  contents in newborns  as  well as in  the liver and spleen of  growing rats
     in the  case of alimentary  lead  deficiency].  Z. Tierphysiol.  Tierernaehr. Futtermittelkd.
     46: 8-14.

Reichlmayr-Lais, A. M.;  Kirchgessner,  M.  (1981e)  Aktivitats-Veranderungen  verschiedener Enzyme
     im  alimentaren  Blei-Mangel  [Activity  changes of  different enzymes  in alimentary  lead
     deficiency]. Z. Tierphysiol. Tierernaehr. Futtermittelkd. 46: 145-150.

Reichlmayr-Lais,  A.  M.;  Kirchgessner, M.  (1981f) Hamatologische Veranderungen bei  alimentarem
     Bleimangel  [Hematological changes with  alimentary lead  deficiency]. Ann.  Nutr.  Metab. 25:
     281-288.

Reif,  M.  C.;  Constantiner,  A.; Levitt,  M.  F.  (1981) Chronic  gouty nephropathy:  a  vanishing
     syndrome?  N.  Engl.  J. Med.  304:  535-536.

Reigart,  J.  R. ;  Graber, C.   D.  (1976) Evaluation  of  the humoral  immune  response  of  children
     with low  level  lead exposure.  Bull.  Environ. Contain.  Toxicol.  16:  112-117.

Reiter,  L.  W.  (1982)  Age-related effects of chemicals on the  nervous system. In:  Hunt,  V.  R.;
     Smith,  M.  K. ; Worth,  D.  Environmental  factors  in human growth  and  development.  Cold
     Spring  Harbor,  NY: Cold  Spring  Harbor  Laboratory;  pp.   245-267.  (Banbury  report  11).

Reiter,  L.  W.; MacPhail,  R.  C.   (1982)  Factors  influencing motor activity measurements  in
     neurotoxicology.  In:  Mitchell,  C.  L. ,  ed.  Nervous system toxicology. New York, NY:  Raven
     Press;  pp.  45-65. (Dixon,  R.  L., ed.  Target organ toxicology series).

Reiter,  L.  W. ;  Anderson, G.  E. ;  Laskey,  J.  W. ;  Cahill,  D.  F.  (1975) Developmental  and be-
     havioral  changes  in  the rat  during  chronic exposure  to lead.  Environ. Health Perspect.
     12:  119-123.

Remmer,  H.;  Schenkman,  J. ;  Estabrook,  R.  W. ;  Sasame,  H. ;  Gillette,  J.;  Narasimhulu,  S. ;
     Cooper, D. Y.; Rosenthal,  0.  (1966) Drug interaction with hepatic microsomal cytochrome.
     Mol.  Pharmacol.  2:  187-190.

                                           12-349

-------
Repko, J. D.;  Corum,  C.  R.;  Jones, P.  D.;  Garcia, L. S., Jr. (1978) The effects of inorganic
     lead on  behavioral  and  neurologic function.  Cincinnati, OH:  U.S.  Department of Health,
     Education,  and  Welfare,  National   Institute  for  Occupational Safety  and  Health;  DHEW
     (NIOSH) publication no.  78-128; 92 p.

Reyes, A.; Mercado, E. ;  Goicoechea, B.; Rosado, A.  (1976) Participation of membrane sulfhydryl
     groups in the epididymal  maturation of human and rabbit spermatozoa. Fertil. Steril. 27:
     1452-1458.

Reyners, H. ,  Gianfelici  de Reyners, E. ; Maisin, J.  R.  (1979) An ultrastructural study of the
     effects of  lead  in  the  central nervous system  of  the rat.  In: International conference:
     management  and  control   of heavy  metals  in  the environment;  September;  London,  United
     Kingdom.  Edinburgh, United Kingdom: CEP Consultants, Ltd.; pp.  58-61.

Rice, D.  C. ;  Gilbert,  S.  G.  (1985)  Low-level lead  exposure from birth produces behavioral
     toxicity (DRL) in monkeys. Toxicol. Appl.  Pharmacol. 80:  421-426.

Rice,  D.   C. ;  Willes,  R.  F.   (1979)  Neonatal  low-level  lead  exposure  in  monkeys  (Macaca
     fascicularis): effect on  two-choice non-spatial  form discrimination. J. Environ. Pathol~
     Toxicol.  2:  1195-1203.

Rice, D. C.; Gilbert,  S.  G.;  Willes, R.  F.  (1979) Neonatal low-level lead exposure in monkeys:
     locomotor  activity,  schedule-controlled  behavior,  and  the  effects  of  amphetamine.
     Toxicol.  Appl. Pharmacol.  51:  503-513.

Rice, D.  C.  (1984) Behavioral  deficit  (delayed  matching to sample)  in monkeys exposed from
     birth to low levels of lead.  Toxicol.  Appl. Pharmacol. 75: 337-345.

Rice, D. C.  (1985a)  Chronic  low-lead exposure  from  birth produces deficits in discrimination
     reversal in monkeys. Toxicol.  Appl. Pharmacol. 77:  201-210.

Rice, D.  C.  (1985b)  Effect  of  lead on schedule-controlled behavior in monkeys.  In:  Behavior
     pharmacology:  the current status. New York, NY:  Alan R. Liss,  Inc., pp. 473-486.

Richet,  G.;  Albahary,  C. ;  Ardaillou,  R. ;  Sultan,  C.;  Morel-Maroger,  A.  (1964) Le  rein du
     saturnisme chronique  [The  kidney in chronic  lead  poisoning].  Rev. Fr. Etud. Clin. Biol
     9:  188-196.

Richet, G.; Albahary, C.;  Morel-Maroger, L. ; Guillaume,  P.;  Galle, P.  (1966) Les alterations
     renales  dans  23  cas  de saturnisme professionnel  [Renal changes  in  23 cases of occupa-
     tional lead poisoning].  Bull.  Mem.  Soc. Med.  Hop. Paris 117: 441-466.

Richet,  G.;  Mignon,  F. ;  Ardaillou, R.  (1965) Goutte secondaire des  nephropathies chroniques
     [Gout secondary  to chronic nephropathy]. Presse Med. 73:  633-638.

Rippe,  D.  F.; Berry,  L. J.  (1973) Metabolic manifestations  of  lead acetate sensitization to
     endotoxin in mice.  J. Reticuloendothel. Soc.  13: 527-535.

Robins, J. M.; Cullen,  M.  R.; Connors,  B.  B.;  Kayne, R. D.  (1983) Depressed thyroid  indexes
     associated with  occupational   exposure  to inorganic lead.  Arch.  Int.  Med.  143:  220-224.

Robinson, T.  R.  (1976)  The health of long service tetraethyl  lead  workers. J. Occup.  Med. 18-
     31-40.


                                          12-350

-------
Robinson, R.  0.  (1978) Tetraethyl lead poisoning  from gasoline sniffing. J.  Am.  Med.  Assoc.
     240: 1373-1374.

Robinson, S.  H.;  Cantoni,  0.;  Costa,  M.  (1984)  Analysis of  metal-induced DMA  lesions  and
     DNA-repair replication in mammalian cells. Mutat. Res. 131: 173-181.

Robinson, G. ;  Baumann, S. ;  Kleinbaum,  D. ;  Barton,  c. ;  Schroeder,  S. ;  Mushak,  P.;  Otto, D.
     (1985) Effects  of low  to moderate lead  exposure on brainstem auditory evoked potentials
     in  children.  In:  Environmental  health, doc. 3 (extended abstracts  from the second inter-
     national symposium on  neurobehavioral  methods in  occupational and environmental health;
     August; Copenhagen, Denmark. Copenhagen,  Denmark: World Health Organization; pp. 177-182.

Roels,  H.  A.;   Lauwerys,  R.  R.; Buchet,  J.  P.;  Vrelust,  M.-T.  (1975a)  Response  of   free
     erythrocyte  porphyrin  and  urinary-6-aminolevulinic  acid in  men  and  women moderately
     exposed to lead.  Int. Arch. Arbeitsmed. 34: 97-108.

Roels,  H. A.;  Buchet, J.-P.;  Lauwerys, R.  R.;  Sonnet, J.  (1975b)  Comparison of jji vivo effect
     of  inorganic  lead  and  cadmium on  glutathione  reductase system  and 6-amTnolevulinate
     dehydratase  in  human erythrocytes. Br.  J.  Ind. Med. 32: 181-192.

Roels,  H.;  Buchet,  J.-P.;   Lauwerys,  R.;  Hubermont,  G.;  Bruaux, P.;  Claeys-Thoreau,  F.;
     Lafontaine,  A.; Van Overschelde, J.  (1976) Impact of air pollution  by lead on the  heme
     biosynthetic pathway in  school-age children. Arch.  Environ. Health  31:  310-316.

Roels,  H.;  Lauwerys, R.; Buchet, J.-P.; Hubermont,  G. (1977)  Effects of  lead on  lactating  rats
     and their  sucklings. Toxicology 8: 107-113.

Roels,  H.  A.; Buchet, J.-P.;  Bernard,  A.;  Hubermont, G.;  Lauwerys,  R.  R.;  Masson,  P.  (1978a)
      Investigations  of factors influencing  exposure and  response to lead,  mercury,  and cadmium
      in man and in animals.  Environ.  Health Perspect. 25:  91-96.

Roels,  H.;  Hubermont, G.;  Buchet,  J.-P.;   Lauwerys, R.   (1978b)  Placental  transfer of  lead,
      mercury,  cadmium, and  carbon monoxide  in women:  III.  factors  influencing the accumulation
      of heavy metals  in the  placenta and the  relationship  between metal  concentration in the
      placenta and in maternal and cord blood.  Environ. Res.  16: 236-247.

Roels,  H.  A.;  Balis-Jacques,  M.  N.;  Buchet, J.-P.;  Lauwerys,  R. R. (1979) The influence of sex
      and of chelation therapy on erythrocyte protoporphyrin and urinary 6-aminolevulinic acid
      in lead-exposed workers. J. Occup.  Med. 21: 527-539.

 Rom, W. N.  (1976) Effects  of lead on the female and reproduction: a review. Mt. Sinai J.  Med.
      43: 542-552.

 Rosen,   J.  f.   (1983)  The  metabolism of  lead  in isolated bone cell populations: interactions
      between lead and calcium. Toxicol.  Appl.  Pharmacol.  71: 101-112.

 Rosen,  J. F. (1985) Metabolic and cellular effects of lead: a  guide to  low  level  lead toxicity
      in  children.  In:  Mahaffey, K.  R.  ,  ed.  Dietary  and  environmental   lead:  human health
      effects.  Amsterdam,   The   Netherlands:   Elsevier/North-Holland   Biomedical  Press;  pp.
      157-185.

 Rosen,  J.   F.;  Chesney,   R.   W.  (1983)   Circulating  calcitriol  concentrations  in  health and
      disease. J.  Pediatr. (St.  Louis) 103:  1-7.


                                            12-351

-------
Rosen, J. F.; Markowitz,  M.  E.  (1980) D-penicillamine:  its  actions on lead transport in bone
     organ culture.  Pediatr.  Res.  14:  330-335.

Rosen, J.  F.;  Zarate-Salvador, C.;  Trinidad, E.  E.  (1974)  Plasma lead  levels  in  normal  and
     lead-intoxicated children.  J.  Pediatr. (St.  Louis) 84: 45-48.

Rosen, J. F.; Chesney,  R.  W.;  Hamstra, A.  J.; DeLuca, H. F.; Mahaffey, K. R.  (1980) Reduction
     in 1,25-dihydroxyvitamin 0 in  children with  increased  lead absorption.  N.  Engl.  J. Med
     302:  1128-1131.

Rosen, J. F.; Chesney,  R.  W.;  Hamstra, A.  J.; DeLuca, H. F.; Mahaffey, K. R.  (1981) Reduction
     in 1,25-dihydroxyvitamin D in children with increased lead absorption.  In:  Brown, S.  S.;
     Davis,  D.  S. ,  eds.  Organ-directed  toxicity:  chemical indices and  mechanisms.  New York!
     NY:  Pergamon Press; pp.  91-95.

Rosen, I.;  Wildt,  K. ;  Gullberg,  B. ; Berlin,  M.   (1983)  Neurophysiological  effects  of lead
     exposure.  Scand.  J. Work Environ.  Health 9:  431-441.

Rosen, J. B.; Berman, R. F.;  Beuthin,  F.  C.;  Louis-Ferdinand, R. T. (1985) Age of testing as  a
     factor  in  the behavioral  effects of  early  lead  exposure in rats.  Pharmacol. Biochem
     Behav.  23:  49-54.

Rosenfeld,  J.  B.  (1974)   Effect  of  long-term   allopurinol  administration on  serial  GFR  in
     normotensive and hypertensive  hyperuricemic subjects. Adv. Exp.  Med. Biol.  41B: 581-596.

Rosenkranz,   H.  S.; Poirier,  L.  A. (1979) Evaluation  of  the  mutagenicity  and  DNA-modifying
     activity of  carcinogens and  noncarcinogens in microbial  systems.  J.  Natl.  Cancer Inst
     62:  873-892.

Roth, H.-P.; Kirchgessner, M. (1981) Zur alimentaren Zinkabhangigkeit der 6-Aminolavulinsaure-
     Dehydratase [Dependence of delta-aminolaevulinic acid dehydratase upon alimentary  zinc].
     Z. Tierphysiol.  Tiernaehr. Futtermittelkd.  46: 59-63.

Rummo, J.  H.  (1974) Intellectual and  behavioral effects of  lead  poisoning  in children [dis-
     sertation]. Chapel  Hill,  NC:  University of  North Carolina.   Available  from:   University
     Microfilms, Ann Arbor, MI; publication no.  74-26,930.

Rummo, J.  H.;  Routh,  D.  K.;  Rummo,  N.  J.;  Brown, J.  F.  (1979)  Behavioral  and neurological
     effects of symptomatic  and asymptomatic lead exposure in  children. Arch. Environ.  Health
     34:  120-124.

Rutter, M.  (1980)  Raised  lead  levels and  impaired cognitive/behavioral functioning. Dev. Med
     Child Neurol.  (Suppl.) 42: 1-26.

Rutter,  M.  (1983)  Scientific  issues  and  state  of the art  in 1980.  In:  Rutter,  M.; Russell
     Jones, R. , eds.  Lead versus  health:  sources  and effects of  low  level lead exposure. New
     York, NY:  John Wiley and Sons; pp. 1-15.

Sabbioni, E.; Marafante,  E.  (1976) Identification of  lead-binding  components in rat liver:  in
     vivo study. Chem.  Biol.  Interact. 15:  1-20.

Sachs, H. K. (1978) Intercurrent infection  in lead poisoning. Am.  J. Dis.  Child. 132:  315-316.
                                          12-352

-------
Sachs,  H.  K.;  Krall,  V.; McCaughran,  D.  A.;  Rozenfeld,  I.  H.;  Youngsmith, N.;  Growe, G.;
     Lazar, B.   S. ;  Novar,  L. ;  O'Connell, L.; Rayson, B. (1978) IQ following treatment of lead
     poisoning:  a patient-sibling comparison. J. Pediatr. (St. Louis) 93: 428-431.

Sachs,  H.  K.;  McCaughran,  D.  A.;  Krall,  V.;  Rozenfeld,  I.  H. ;  Youngsmith, N.  (1979) Lead
     poisoning without encephalopathy: effect of early diagnosis on neurologic and psychologic
     salvage. Am. J. Dis. Child.  133: 786-790.

Sachs,  H.  K.;  Krall, V.;  Drayton,  M.  A.  (1982)  Neuropsychological   assessment  after lead
     poisoning without encephalopathy. Percept. Motor Skills  54: 1283-1288.

Saenger,  P.; Forster,  E.; Kream,  J. (1981)  6p-hydroxycortisol:  a  noninvasive indicator  of
     enzyme  induction. J. Clin. Endocrinol. Metab. 52:  381-384.

Saenger,  P.;  Markowitz,   M.  E. ;  Rosen,  J.  F.  (1982a)  6p-hydroxycortisol  (6£OHF) as index  of
     microsomal  inhibition in  lead  burdened children. Dev. Pharmacol. 16:  130A.

Saenger,  P.; Markowitz,  M.  E.; Rosen,  J.  F.  (1984) Depressed excretion of  6B-hydroxycortisol
      in lead-toxic  children. J. Clin. Endocrinol.  Metab. 58:  363-367.

Saenger,  P.; Rosen,  J.  F.;  Markowitz,  M.  E.  (1982b)  Diagnostic significance  of edetate  di-
      sodium  calcium testing  in  children with increased  lead absorption. Am.  J. Dis.  Child.
      136:  312-315.

Sakurai,  H.; Sugita,  M.; Tsuchiya,  K.   (1974)  Biological  response and  subjective  symptoms  in
      low  level  lead exposure.  Arch.  Environ.  Health  29:  157-163.

Salaki, J.;  Louria, D.  B.; Thind,  I. S.  (1975) Influence  of lead intoxication on experimental
      infections.  Clin. Res. 23: 417A.

Sandberg,  A.  A., ed.  (1982) Sister chromatid exchange. New York,  NY:  Alan R.  Liss.  (Sandberg,
      A. A.,  ed.  Progress and topics in  cytogenetics:  v. 2).

Sandstead,  H.  H. (1967)  Effect of  chronic lead intoxication on n\ vivo I131 uptake by the rat
      thyroid.  Proc. Soc.  Exp.  Biol. Med.  124:  18-20.

Sandstead,  H.  H.;  Michelakis, A. M.; Temple,  T.  E.  (1970a) Lead intoxication:  its effects on
      the  renin-aldosterone response  to  sodium deprivation.  Arch.  Environ. Health 20: 356-363.

Sandstead,   H.  H.;   Orth, D.   N.;   Abe,  K.;  Stiel,  J.  (1970b)  Lead  intoxication:  effect on
      pituitary and  adrenal  function  in man.  Clin.  Res.  18: 76.

Sandstead, H.  H.; Stant, E.  G.;  Brill,  A.  B.; Arias, L. I.;  Terry, R. T. (1969) Lead intoxica-
      tion and  the thyroid.  Arch.  Int. Med.  123: 632-635.

Santos-Anderson, R. M. ;  Tso,  M.  0.  M.; Valdes,  J.  J.; Annau, Z. (1984) Chronic lead adminis-
      tration in neonatal rats: electron microscopy of the retina. J. Neuropathol. Exp.  Neurol.
      43:  175-187.

 Sarto, F. ;  Stella, M.;  Acqua,  A.   (1978)  Studio citogenetico su  un  gruppo di lavoratori  con
      indici di  aumentato assorbimento  di  piombo  [Cytogenetic  studies  in  20  workers  occupa-
      tional^ exposed to lead].  Med. Lav. 69:  172-180.
                                           12-353

-------
Sassa, S.;  Granick,  J.  L.;  Granick,  S.;  Kappas,  A.;  Levere,  R.  D.  (1973)  Studies  in  lead
     poisoning:  I.  microanalysis of erythrocyte protoporphyrin levels by spectrofluorometry 1n
     the  detection  of chronic  lead intoxication  in  the subclinical  range.  Biochem.  Med.  8-
     135-148.

Sassa, S. ;  Whetsell,  W.  0.,  Jr.; Kappas,  A.  (1979)  Studies on porphyrin-heme biosynthesis 1n
     organotypic cultures of  chick  dorsal  root ganglia: II. the effect of lead.  Environ.  Res
     19:  415-426.

Sato, S.  M.  ; Frazier, J.  M.;  Goldberg, A. M.  (1984) Perturbation of a hippocampal zinc-binding
     pool after postnatal lead exposure in rats. Exp.  Neurol. 85:  620-630.

Sauerhoff,  M.  W.;  Michaelson,  I.  A.  (1973)  Hyperactivity  and brain  catecholamines  in lead-
     exposed developing rats.  Science (Washington,  DC) 182: 1022-1024.

Sborgia,  G.;  Assennato,  G.;  L'Abbate,  N.; DeMarinis, L.;  Paci, C.; DeNicolo,  M.;  DeMarinis,
     G. ;  Montrone,  N.; Ferrannini,  E. ;  Specchio,  L. ;  Masi, G. ; Olivieri, G.  (1983) Compre-
     hensive neurophysiological evaluation of lead-exposed workers.  In: Gilioli, R. ; Cassitto
     M. G.;  Fpa, V.,  eds.  Neurobehavioral  methods in occupational  health:  proceedings of the
     international   symposium  on  neurobehavioral  methods  in occupational health;  June 1982;
     Como and Milan,  Italy.  London, United Kingdom Pergamon Press;  pp.  283-294. (Advances in
     the biosciences: v.  46).

Schlick,  E.;  Friedberg,  K.  D.  (1981)  The  influence  of   low  lead  doses  on  the  reticulo-
     endothelial system and leucocytes of mice. Arch.  Toxicol. 47:  197-207.

Schlipkoter,  H.-W.;   Frieler,  L.   (1979)  Der  Einfluss kurzzeitiger  Bleiexposition  auf  die
     Bakterienclearance der Lunge  [The influence of  short-term lead exposure on the bacterial
     clearance  of  the lung].  Zentralbl.  Bakteriol.   Parasitenkd.  Infektionskr.  Hyg.  Abt.  l-
     Orig.  Reihe B 168: 256-265.

Schlipkoter, H.-W.;  Winneke,  G.  (1980) Behavioral  studies  on the  effects of ingested  lead on
     the  developing  central   nervous  system  of rats.  In: Environmental  quality  of  life:  lead
     environmental  research program 1976-80.  Brussels,  Luxembourg:  Commission of the European
     Communities; pp. 127-134.

Schmid, E.;  Bauchinger,  M.;  Pietruck, S.; Hall, G. (1972)  Die cytogenetische Wirkung von Ble1
     in menschlichen peripheren Lymphocyten  iji vitro und jm vivo  [The  cytogenetic effect of
     lead in human  peripheral  lymphocytes i_n  vitro  and _in vivo].  Mutat.  Res.  16:  401-406.

Schnitker,  M.  A.;  Richter, A.  B.   (1936)  Nephritis   in  gout.  Am.  J.  Med.  Sci.  192:  241-252.

Schrauzer,  G. N.;  Kuehn,  K. ;  Hamm, D.  (1981)  Effects of dietary selenium  and  of  lead on the
     genesis of spontaneous mammary tumors in mice. Biol. Trace Elem.  Res. 3:  185-196.

Schroeder,  H. A.;  Mitchener,  M. (1971) Toxic effects of trace elements on the reproduction of
     mice and rats. Arch. Environ. Health 23: 102-106.

Schroeder,  S.   R.;   Hawk,  B.   (1986)  Child-caregiver environmental  factors  related  to  lead
     exposure  and  IQ.  In:  Schroeder,  S.   R., ed. Toxic   substances  and mental retardation:
     neurobehavioral  toxicology and  teratology.   Washington,  DC:   in  press.  (AAMD monograph
     series).
                                          12-354

-------
Schroeder, H.  A.;  Mitchener, M. ;  Nason,  A.  P.  (1970) Zirconium,  niobium,  antimony, vanadium
     and lead in rats:  life term studies.  J.  Nutr.  100: 59-68.

Schroeder, S.  R.;  Hawk,   B.;  Otto, D.  A.;  Mushak,  P.;  Hicks,  R.  E.  (1985)  Separating the
     effects  of  lead and  social  factors on IQ.  In:  Bornschein, R. L.; Rabinowitz, M. B., eds.
     The  second  international   conference  on  prospective  studies  of  lead;  April  1984;
     Cincinnati, OH.  Environ. Res.  38:  144-154.

Schumann, G.  B. ;  Lerner,  S.  I.; Weiss, M. A.;  Gawronski, L. ; Lohiya, G.  K. (1980)  Inclusion-
     bearing  cells  in  industrial workers  exposed to lead.  Am. J.  Clin.  Pathol.  74: 192-196.

Schumer,  W.;  Erve,  P.   R.  (1973) Endotoxin sensitivity of  adrenalectomized rats treated with
     lead acetate.  J.  Reticuloendothel. Soc.  13: 122-125.

Schwanitz, G.;  Lehnert,  G.; Gebhart,  E. (1970)  Chromosomenschaden bei  beruflicher  Bleibe-
     lastung [Chromosome  damage  after occupational   exposure  to lead]. Dtsch. Med. Wochenschr.
     95:  1636-1641.

Schwanitz, G.;  Gebhart,  E.;  Rott,  H.-D.,  Schaller,  K.-H.;  Essing,  H.-G.; Lauer,  0.;  Prestele,
     H.  (1975)  Chromosomenuntersuchungen  bei  Personen mit  beruflicher Bleiexposition [Chromo-
     some investigations  in  subjects with  occupational lead  exposure]. Dtsch. Med. Wochenschr.
     100: 1007-1011.

Schwartz, J.;  Angle,  C. ;  Pitcher,  H.  (1986) The relationship between childhood blood lead  and
     stature.  Pediatrics  77: 281-288.

Scoppa,  P.;  Roumengous,  M. ; Penning, W.  (1973) Hepatic  drug metabolizing activity  in  lead-
     poisoned  rats. Experientia  29: 970-972.

Scott,  K. M. ;  Hwang,  K.  M.;  Jurkowitz,   M.;  Brierley,  G.  P.  (1971) Ion  transport by  heart
     mitochondria:  XXIII.  the   effects  of lead  on  mitochondrial  reactions.  Arch.  Biochem.
     Biophys.  147: 557-567.

Scroczynski,  J.; Zajusz, K.;  Kossman,  S.;  Wegiel,  A.   (1967)  Effect  of experimental  lead
     poisoning on  the  development  of arteriosclerosis.   Pol.  Arch. Med.  Wewn.  38:  641-664.

Seawright,  A.  A.;  Brown, A. W.;  Aldridge,  W.  N. ;  Verschoyle,  R.  D.;  Street,  B.   W.  (1980)
     Neuropathological  changes  caused by trialkyllead  compounds  in the  rat.  Dev.  Toxicol.
     Environ.  Sci. 8: 71-74.

Secchi,   G.   C.;  Rezzonico,  A.; Alessio,  L.   (1968) Variazioni  dell'attivita  Na+-K+-ATPasica
     delle pemj>rane eritrocitarie  nelle  diverse fasi della  intossicazione  saturnina [Changes
     in   Na  -K -ATPase   activity  of   erthrocytic   membranes  in  different  phases  of  lead
     poisoning].  Lav. Med. 22:  191-196.

Secchi,  G. ;  Alessio, L.;  Cambiaghi, G.  (1973)  Na /K -ATPase activity of erythrocyte membranes:
     in   urban  populations  not occupationally exposed  to  lead.   Arch.   Environ.   Health  27:
     399-400.

Secchi,  G.  C.;  Erba, L. ; Cambiaghi,  G. (1974)  Delta-aminolevulinic acid dehydratase  activity
     of  erythrocytes and liver tissue  in man:  relationship to  lead  exposure. Arch.  Environ.
     Health  28:  130-132.
                                           12-355

-------
Selander, S.; Cramer,  K.  (1970) Interrelationships between  lead  in blood, lead in urine, and
     ALA in urine during lead work. Br. J. Ind. Med. 27: 28-39.

Selevan, S. G. ;  Landrigan,  P.  J. ; Stern, F.  B. ; Jones, J. H.  (1984) Mortality of lead smelter
     workers.  Am. J. Epidemiol. 122:  673-683.

Selye,  H.;  Tuchweber,  B. ;  Bertok, L.  (1966)  Effect of lead acetate  on  the susceptibility of
     rats to bacterial  endotoxins.  J. Bacteriol.  91: 884-890.

Seppalainen,  A.  M. ;  Hernberg,  S.  (1980) Subclinical  lead  neuropathy.   Am.  J.  Ind.  Med.  1-
     413-420.

Seppalainen, A.  M.;  Tola,  S.;  Hernberg,  S. ;  Kock,  B.  (1975)  Subclinical  neuropathy at "safe"
     levels of lead exposure.  Arch. Environ.  Health 30: 180-183.

Seppalainen, A.  M.;  Hernberg,  S.;  Kock,  B.  (1979)  Relationship between  blood lead levels and
     nerve conduction velocities. Neurotoxicology 1: 313-332.

Seppalainen,  A.  M.; Hernberg,  S.; Vesanto,   R.;  Kock, B. (1983)  Early  neurotoxic effects of
     occupational lead exposure: a prospective study.  Neurotoxicology 4:   181-192.

Seto, D.  S. Y.;  Freeman,  J. M.  (1964)  Lead  neuropathy in childhood.  Am. J.  Dis.  Child. 107-
     337-342.

Shaheen,  S.  J.   (1984)  Neuromaturation and  behavior  development:   the case of childhood lead
     poisoning. Dev. Psychol.  20: 542-550.

Shannon,  H.   S.; Williams,  M.  K.;  King,  E.   (1976)  Sickness  absence   of lead  workers and
     controls. Br.  J. Ind.  Med. 33: 236-242.

Shapiro, I. M.;  Marecek,  J. (1984) Dentine  lead  concentration as  a predictor of neuropsycho-
     logical functioning in inner-city children. Biol. Trace Elem.  Res. 6:  69-78.

Shapiro, I. M.;  Oobkin,  B.; Tuncay,  0. C.; Needleman, H. L.  (1973) Lead  levels  in dentine and
     circumpulpal dentine of deciduous teeth of normal and lead poisoned  children. Clin.  Chim
     Acta 46:  119-123.

Sharma,  R.  M.;   Buck,  W.  B. (1976)  Effects  of  chronic  lead  exposure on  pregnant  sheep and
     their progeny.  Vet.  Toxicol. 18: 186-188.

Sheffet, A.;  Thind, I.; Miller, A.  M. ;  Louria,  D.  B.   (1982) Cancer mortality in a pigment
     plant utilizing lead and zinc chromates. Arch.  Environ.  Health 37: 44-52.

Shellenberger, M. K.  (1984) Effects  of early lead exposure on neurotransmitter  systems in the
     brain. A review with commentary. Neurotoxicology 5:  177-212.

Shelton, K. R.; Egle, P.  M.  (1982) The proteins of lead-induced intranuclear inclusion bodies
     J. Biol.  Chem.  257:  11802-11807.

Shen-Ong, G.  L.  C.;  Keath,  E.  J.; Piccoli,  S.  P.;  Cole, M.  D.  (1982) Novel myc oncogene RNA
     from abortive immunoglobulin-gene recombination in mouse  plasmacytomas. CeTT 31 (Part !)•
     443-452.
                                          12-356

-------
Shenker, B. J.;  Matarazzo,  W.  J.; Hirsch,  R.  L.;  Gray, I. (1977) Trace metal modification of
     immunocompetence: 1.  effect of trace metals in the cultures on in vitro transformation of
     B lymphocytes. Cell.  Immunol. 34: 19-24.

Shigeta, S.;  Misawa,  T.;  Aikawa, H.  (1977) Effect of lead on operant behaviour in rats. Tokai
     J. Exp. Clin. Med. 2: 153-161.

Shigeta, S.;  Misawa,  T.;  Aikawa, H. ;  Hirase,  F.;  Nagata, M. (1979) Effects of lead on Sidman
     avoidance behavior by lever pressing in rats. Nippon  Eiseigaku Zasshi  34: 677-682.

Shiina, Y.; Abe, E.  Miyaura, C.; Tanaka,  H.;  Yamada,  S.; Ohmori, M. ; Nakayama,  K.; Takayama,
     H.; Matsunaga,  I.;  Nishii, Y.;  Deluca, H. F. ; Suda,  T.  (1983) Biological activity of 24,
     24-difluoro-lcr,25-dihydroxyvitamin  D3  and   la,25-dihydroxyvitamin   D3-26,23-lactone   in
     inducing  differentiation  of  human  myeloid leukemia cells.  Arch.  Biochem.   Biophys. 220:
     90-94.

Shimojo, N.;  Asano, N.; Yamaguchi,  S.  (1983) Lead  absorption after low  level  lead exposure and
     behavioral  effects  of  such  exposure in neonatal  rats.  Nippon  Eiseigaku  Zasshi 38:
     797-805.

Shlossman,  M.;  Brown, M.;  Shapiro,  E.;  Dziak, R.  (1982) Calcitonin effects on  isolated bone
     cells. Calcif. Tissue  Int.  34:  190-196.

Silbergeld,  E.  K.;  Adler,  H.   S.  (1978) Subcellular mechanisms of lead neurotoxicity.  Brain
     Res.  148:  451-467.

Silbergeld,  E.  K. ;  Goldberg,  A. M.  (1973)  A  lead-induced behavioral disorder.  Life  Sci.  13:
     1275-1283.

Silbergeld,  E.  K.;  Goldberg,   A.  M.  (1974a) Hyperactivity:  a  lead-induced behavior disorder.
     Environ.  Health Perspect.  7: 227-232.

Silbergeld,  E.  K.;  Goldberg,  A.  M.  (1974b)   Lead-induced  behavioral  dysfunction:  an animal
     model of hyperactivity.  Exp. Neurol.  42:  146-157.

Silbergeld, E.  K.;  Lamon,  J.  M. (1980) Role  of  altered heme synthesis  in lead  neurotoxicity.
      J. Occup. Med.  22:  680-684.

Silbergeld,  E.  K.;  Adler,  H.   S.;  Costa,  J.   L.  (1977)  Subcellular  localization  of  lead in
      synaptosomes. Res.  Commun. Chem. Pathol.   Pharmacol. 17: 715-725.

 Silbergeld,  E.  K.;  Miller,  L.  P.;  Kennedy, S.;  Eng, N.  (1979) Lead,  GABA,  and seizures:   ef-
      fects of  subencephalopathic lead exposure on seizure  sensitivity and GABAergic function.
      Environ. Res. 19: 371-382.

 Silbergeld,  E.  K.;  Hruska,  R.  E.;  Miller,  L.  P.; Eng,  N.  (1980a) Effects of  lead  in  vivo  and
      HI vitro on GABAergic neurochemistry. J.  Neurochem.  34: 1712-1718.

 Silbergeld,  E.  K. ;  Wolinsky,  J. S.;  Goldstein,  G.  W.   (1980b)  Electron  probe  microanalysis of
      isolated brain  capillaries  poisoned with  lead.  Brain Res.  189:  369-376.

 Silbergeld,  E.  K.;  Hruska, R.   E.;  Bradley, D. Lamon,  J.  M.; Frykholm,  B. C.  (1982) Neurotoxic
      aspects  of porphyrinopathies:  lead and succinylacetone. Environ.  Res. 29:  459-471.


                                            12-357

-------
 Sillman,  A.  J.; Bolnick, 0.  A.;  Bosetti,  J. B.;  Haynes,  L.  W.;  Walter, A.  E.  (1982)  The ef-
      fects  of  lead  and  of  cadmium on  the mass  photoreceptor  potential:   the  dose-response
      relationship.  Neurotoxicology 3:  179-194.

 Silva,  P. A.;  Hughes, P.;  Faed,  J.  M.  (1986a)  Blood lead levels  in 579 Dunedin eleven year old
      children.  N.  Z.  Med.  J.  99:  179-183.

 Silva,  P.  A.; Hughes,  P.;  Williams, S.;  Faed,  J.  M.  (1986b)  Blood lead,  intelligence,  reading
      attainment,  and behaviour in  eleven  year old children  in Dunedin,  New Zealand. J.  Child
      Psychol.  Psychiatry:  provisionally accepted for publication.

 Silver,  W.;  Rodriguez-Torres,  R.  (1968)  Electrocardiographic studies  in  children with  lead
      poisoning.  Pediatrics  41:  1124-1127.

 Simmon,  V.  F.  (1979)  In  vitro  mutagenicity assays  of  chemical  carcinogens  and  related
      compounds with Salmonella  typhimurium.  J.  Natl.  Cancer Inst.  62:  893-899.

 Simmon,  V.  F. ;  Rosenkranz,  H.  S. ; Zeiger, E. ;  Poirier,  L.  A.   (1979) Mutagenic  activity of
      chemical  carcinogens  and related compounds in the intraperitoneal host-mediated assay  J
      Natl.  Cancer Inst.  62:  911-918.                                                      '  '

 Singer,  R. ;  Valciukas,  J.  A.;  Lilis,  R.  (1983)  Lead exposure and  nerve conduction velocity:
      the  differential  time  course of  sensory and motor  nerve  effects.    Neurotoxicology 4'
      193-202.

 Singh,  N. ;  Donovan,  C.  M.;  Hanshaw, J. B.  (1978) Neonatal lead  intoxication  in  a prenatally
      exposed  infant.  J.  Pediatr.  (St.  Louis) 93:  1019-1021.

 Sirover,  M.  A.;  Loeb,  L.  A.  (1976)  Infidelity  of DMA  synthesis  jm  vitro:  screening for
      potential metal  mutagens or carcinogens.  Science (Washington, DC) 194:  1434-1436.

 Smith,  F.   L. ,  2nd;  Rathmell,  T.  K. ;  Marcil,  G.   E.  (1938)  The  early diagnosis  of acute and
      latent plumbism. Am.  J.  Clin.  Pathol.  8:  471-508.

 Smith,  C. M.;  DeLuca, H.  F.;  Tanaka, Y.; Mahaffey, K.  R. (1978)  Stimulation of lead absorption
      by vitamin D administration. J. Nutr.  108: 843-847.

 Smith,  C.  M.  ; DeLuca,  H.  F.; Tanaka, Y. ;  Mahaffey,  K.  R.  (1981) Effect of lead ingestion on
      functions of vitamin  D and its metabolites.  J. Nutr.  Ill: 1321-1329.

 Smith,  M. ;  Delves,  T. ;  Lansdown,  R. ; Clayton,  B. ; Graham,  P.  (1983) The effects  of  lead
      exposure on  urban children:  the  Institute of Child  Health/Southampton  study.  Dev.  Med
      Child  Neurol.  25(5):  suppl.  47.

'Snodgrass,  S.  R.  (1978) Use of 3H-muscimol  for  GABA  receptor studies. Nature  (London)  273-
      392-394.

 Snowdon,  C.  T.  (1973)  Learning deficits in lead-injected  rats.  Pharmacol.  Biochem. Behav  1-
      599-603.

 Sobotka,  T. J.;  Cook, M.  P.  (1974) Postnatal lead acetate exposure in rats:  possible relation-
      ship  to  minimal  brain dysfunction. Am. J.  Ment. Defic. 79:  5-9.
                                           12-358

-------
Sobotka, T.  J. ;  Brodie,  R.  E.; Cook,  M.  P.  (1975)  Psychophysiologic  effects  of early lead
     exposure.   Toxicology 5:  175-191.

Sommers, S.  C.;  Churg,  J. (1982)  Kidney pathology in hyperuricemia and  gout.  In:  Yu, T.-F.;
     Berger, L.,  eds. The kidney in gout and hyperuricemia. Mount Kisco, NY: Futura Publishing
     Company; pp. 95-174.

Sontag, J.  M. ; Page, N.  P.; Saffiotti, U.  (1976)  Guidelines for carcinogen bioassay  in small
     rodents. Bethesda,  MD: U.S.  Department of Health, Education and Welfare, National Cancer
     Institute; report no. NCI-CG-TR-1. DHEW publication no. (NIH) 76-801.

Sorrell, M.; Rosen,  J.  F. ;  Roginsky,  M. (1977)  Interactions of lead, calcium,  vitamin D, and
     nutrition in lead-burdened children.  Arch. Environ. Health 32: 160-164.

Sotelo, C.;  Palay,   S.  L.  (1971)  Altered  axons and  axon  terminals  in the lateral vestibular
     nucleus of  the  rat:  possible  example  of axonal  remodeling.  Lab.  Invest.  25:   653-671.

Soyka,  L.  F.; Joffe, J.  M. (1980)  Male mediated drug  effects on offspring.  In: Schwarz, R. H.;
     Yaffe,  S.  J.,   eds.  Drug and chemical  risks  to the  fetus  and  newborn:  proceedings of  a
     symposium; May  1979; New York,  NY.  New York,  NY:  Alan R.  Liss; pp.  49-66.

Specter,  M.  J.;  Guinee,  V. F.;  Davidow,  B. (1971) The unsuitability  of random  urinary  delta
     aminolevulinic  acid samples  as  a screening  test  for lead poisoning.  J.   Pediatr.   (St.
     Louis)  79: 799-804.

Spit,  B. J.; Wibowo, A.  A. E.; Feron,  V. J. ; Zielhuis,  R.  L.  (1981)  Ultrastructural changes  in
     the kidneys of  rabbits treated with lead  acetate.  Arch.  Toxicol.  49:  85-91.

Spivey, G.  H.;  Brown, C. P.; Baloh, R.  W.; Campion,  D.  S.; Valentine, J. L.;  Massey, F. J. ,
     Jr.;  Browdy,  B. L. ; Culver,  B. D. (1979)  Subclinical effects  of chronic  increased  lead
     absorption  - a  prospective study.  I.  Study  design and analysis  of  symptoms. J. Occup.
     Med. 21: 423-429.

Spivey, G.  H.;  Baloh, R. W.;  Brown, C. P.; Browdy,  B.  L.; Campion, D.  S.;  Valentine, J.  L. ;
     Morgan, D.  E. ;  Culver, B.  D.  (1980) Subclinical  effects of chronic increased lead absorp-
     tion  - a prospective study:  III.  neurologic  findings at follow-up examination.  J. Occup.
     Med. 22: 607-612.

Stankovic,  V.;  Jugo, S.  (1976)  Supressive effect of  lead on  antibody response  of rats  to  S.
     typhimurium. Period. Biol.  78(suppl.  1):  64-65.

Stephens,  M. C.  C.; Gerber,  G.  B.  (1981) Development  of glycolipids  and gangliosides in lead
     treated neonatal  rats.  Toxicol. Lett.  7:  373-378.

Stevenson,  A.  J.; Kacew, S. ;  Singhal, R.  L.  (1977) Reappraisal of the use of a  single dose of
      lead for  the  study of  cell  proliferation in kidney, liver, and lung. J.  Toxicol. Environ.
     Health 2: 1125-1134.

Stewart,  D. D.  (1895)  Lead  convulsions:  a study  of  sixteen cases.  Am. J. Med.  Sci.   109: 288-
      306.

Stewart,  W. E.,  II  (1979) The interferon system. New York, NY: Springer-Verlag.
                                           12-359

-------
Stober, T.; Stelte,  W.;  Kunze,  K.  (1983)  Lead  concentrations  in blood, plasma, erythrocytes,
     and  cerebrospinal  fluid  in amyotrophic  lateral  sclerosis. J.  Neurol.  Sci.  61:  21-26.'

Stofen, D. (1974) Blei als Dmweltgift; die verdeckte Bleivergiftung - ein Massenphanomen [Lead
     as  an  environmental  toxin;  hidden lead  poisoning -  a  mass phenomenon]?  Eshwege,  West
     Germany:  G. E.  Schroeder-Verlag.

Stoner, G. D.;  Shimkin,  M. B.;  Troxell, M.  C.;  Thompson,  T.  L. ; Terry, L. S. (1976) Test for
     carcinogenicity of metallic compounds by the pulmonary tumor  response in strain A mice
     Cancer Res. 36: 1744-1747.

Stowe, H. D.;  Goyer,  R.  A. (1971) The reproductive ability and progeny of F! lead-toxic rats
     Fertil.  Steril. 22:  755-760.

Stowe, H.  D. ; Goyer,  R.  A.; Krigman, M.  M. ;  Wilson,  M.;  Gates, M.  (1973) Experimental  oral
     lead toxicity in young dogs: clinical  and morphologic effects.  Arch. Pathol.  95: 106-116.

Studnitz, W.   von; Haeger-Aronsen,  B. (1962) Urinary excretion of amino acids in lead-poisoned
     rabbits.  Acta Pharmacol. Toxicol. 19:  36-42.

Stuik, E. J.  (1974) Biological  response of male and female volunteers to inorganic lead.  Int
     Arch. Arbeitsmed. 33: 83-97.

Stumpf, W.  E.; Sar,  M.;  Grant, L.  D.  (1980) Autoradiographic  localization  of  210Pb and its
     decay products in rat forebrain. Neurotoxicology 1: 593-606.

Stumpf, W. E.;  Sar, M.;  Clark,  S.  A.  (1982)  Brain target sites for 1,25-dihydroxyvitamin D,
     Science (Washington, DC) 215:  1403-1405.

Suga, R.  S. ;  Fischinger,  A.  J.  ; Knoch,  F.  W.  (1981) Establishment of normal values in adults
     for zinc protoporphyrin (ZPP)  using hematofluorometer: correlation with normal blood lead
     values.  Am. Ind. Hyg. Assoc. J.  42:  637-642.

Suketa, Y.;  Hasegawa, S. ;  Yamamoto, T.  (1979)  Changes in sodium and  potassium  in urine and
     serum of lead-intoxicated rats.  Toxicol.  Appl. Pharmacol.  47: 203-207.

Suketa, Y.;  Ban,  K.;  Yamamoto, T.   (1981)  Effects of  ethanol  and  lead ingestion on urinary
     sodium excretion and  related  enzyme  activity  in rat  kidney.  Biochem.  Pharmacol   30-
     2293-2297.

Swanson, M. S. ; Angle,  C. R.;   Stohs,  S. J.  (1982) Effect of lead chelation therapy with EDTA
     in  children  on  erythrocyte pyrimidine  S'-nucleotidase  and with  cytidine  triphosphate
     levels.  Int.  J. Clin. Pharmacol. Ther. Toxicol.  20: 497-500.

Szold, P.  D.  (1974) Plumbism and iron deficiency [letter]. N.  Engl.  J. Med. 290: 520.

Takaku,  F.;   Aoki,  Y.;  Urata,  G.   (1973)  Delta-aminolevulinic acid  synthetase  activity   in
     erythroblasts  of patients  with  various hematological  disorders. Jpn.  J.  Clin. Haematol
     14:  1303-1310.

Talbott, J. H.  (1949) Diagnosis and  treatment  of  gouty arthritis.  Postgrad. Med.  5: 386-393.

Talbott,  J. H.;  Terplan,  K. L.   (1960)  The kidney in gout. Medicine  (Baltimore)  39: 405-467.


                                          12-360

-------
Talcott,  P.  A.;  Koller,  L.  D.  (1983)  The effect of inorganic  lead  and/or a polychlorinated
     biphenyl  on  the  developing  immune  system  of  mice.  J.   Toxicol.  Environ.  Health 12:
     337-352.

Tanaka,  H.;  Abe,  E.  Miyaura,  C. ;  Kuribayashi, T.;  Konno,  K. ;  Nishii,  Y. ;   Suda,  T.  (1982)
     la,25-dihydroxycholecalciferol and  a  human myeloid leukaemia cell line (HL-60). Biochem.
     J. 204:  713-719.

Tanis, A. L.  (1955) Lead poisoning in children. Am. J. Dis. Child. 89: 325-331.

Tanquerel  des  Planches,  L.  (1839) Traite  des maladies de  plomb ou  saturnines [Treatise on
     lead-related maladies], v.  2. Paris,  France:  Ferra, Libraire-Editeur.

Tapp, J. T.  (1969) Activity, reactivity, and the behavior-directing properties of stimuli. In:
     Tapp, J.  T. ,  ed. Reinforcement and behavior.  New  York, NY: Academic  Press; pp. 146-177.

Tara,  S. ;  Francon,  F.  (1975)  Deux cas  de goutte saturnine a  modalite  mineure  [Two cases of
     saturnine gout of minor modality].  Rhumatologic  (Paris) 5:  238-243.

Taussig, F.  J. (1936) Abortion  spontaneous  and induced:  medical  and social  aspects.  St. Louis,
     MO: The C. V. Mosby Company; pp. Ill,  354-355.

Taylor, D. ;  Nathanson,  J. ;  Hoffer, B.; Olson  L.;  Seiger,  A. (1978) Lead  blockade of norepine-
     phrine-induced  inhibition  of  cerebellar  Purkinje neurons.  J.  Pharmacol.  Exp.   Ther.  206:
     371-381.

Taylor, D. H. ; Noland,  E.  A.;  Brubaker, C.  M. ; Crofton,  K. M. ;  Bull,  R. J.   (1982)  Low  level
     lead  (Pb)  exposure produces  learning deficits  in  young  rat  pups.  Neurobehav. Toxicol.
     Teratol. 4:  311-314.

Teisinger, J.;  Styblova, V.  (1961)  Neurologickyobraz  chronicke otravy  olovem  [Neurological
     picture of chronic lead poisoning]. Acta  Univ. Carol. Med.  Suppl. 14:  199-206.

Tennekoon, G.;  Aitchison,  C.  S.;  Frangia,  J.; Price,  D.  L. ;  Goldberg,  A.  M.  (1979) Chronic
     lead intoxication: effects  on developing  optic nerve. Ann.  Neurol. 5:  558-564.

Tepper, L. B. (1963)  Renal  function subsequent to  childhood plumbism. Arch. Environ.  Health 7:
     76-85.

Thatcher,  R.  W.;  Lester,  M.   L.;  McAlaster,   R. ;  Horst,  R.  (1982)  Effects of  low  levels of
     cadmium and lead on cognitive functioning in  children. Arch. Environ.  Health 37: 159-166.

Thatcher, R.  W.; McAlaster, R.;  Lester,  M.  L.  (1984)  Evoked potentials  related to hair  cadmium
     and  lead  in children.  Ann.  N. Y. Acad.  Sci. 425: 384-390.

Thind,  I.  S.;  Khan,  M. Y.  (1978)  Potentiation of  the neurovirulence  of  Langat virus infection
     by  lead intoxication in  mice. Exp.  Mol.  Pathol.  29: 342-347.

Thind,  I. S.;  Singh,  N.  P.  (1977)  Potentiation of  Langat virus infection  by lead intoxication:
     influence on  host  defenses. Acta Virol.  (Engl.  Ed.) 21:  317-325.

Tilson,  H. A.; Harry,  G. J.  (1982) Behavioral principles  for  use in behavioral toxicology and
     pharmacology.  In:  Mitchell,  C.  L.,  ed.  Nervous system  toxicology.  New York, NY:  Raven
      Press;  pp.  1-27.  (Dixon,  R.  L.,  ed. Target organ toxicology series).

                                           12-361

-------
Timm, F.;  Schulz,  G.  (1966) Hoden und Schwermetalle [Testicles and heavy metals]. Histochenrie
     7:  15-21.

Timpo, A.  E. ;  Amin,  J.  S. ;  Casalino, M.  B. ;  Yuceoglu, A. M. (1979) Congenital lead intoxica-
     tion. J. Pediatr. (St.  Louis) 94: 765-767.

Toews, A.  D. ; Kolber,  A.;  Hayward,  J. ;  Krigman M.  R.;  Morell,  P.  (1978) Experimental lead
     encephalopathy in  the  suckling rat:  concentration of lead in cellular fractions enriched
     in brain capillaries. Brain Res. 147: 131-138.

Tola, S.;  Nordman,  C.-H.  (1977) Smoking and blood lead concentrations in lead-exposed workers
     and an  unexposed population. Environ. Res. 13: 250-255.

Tola, S. ;  Hernberg,  S. ;  Asp,  S.; Nikkanen, J.  (1973)  Parameters indicative of absorption and
     biological  effect  in  new  lead exposure:  a  prospective  study.  Br.  J.  Ind.   Med.  30:
     134-141.

Toriumi,  H. ;  Kawai,  M.  (1981) Free  erythrocyte  protoporphyrin  (FEP) in a  general population,
     workers  exposed  to low-level   lead,  and  organic-solvent  workers.   Environ.   Res.  25:
     310-316.

Trejo, R.  A.;  Di  Luzio, N.  R.  (1971) Impaired detoxification as a mechanism of  lead acetate-
     induced hypersensitivity to endotoxin. Proc. Soc. Exp. Biol. Med. 136: 889-893.

Trejo,  R.  A.;  Di   Luzio,  N.   R. ;   Loose,  L.  D. ;  Hoffman,  E. (1972)  Reticuloendothelial and
     hepatic  functional  alterations following lead acetate  administration. Exp.  Mol. Pathol.
     17:  145-158.

Triebig,  G.; Weltle,  D.;  Valentin, H.  (1984)  Investigations  on  neurotoxicity of chemical
     substances at  the  workplace:  V. determination of the  motor and sensory nerve conduction
     velocity in persons occupationally exposed to lead.  Int. Arch. Occup.  Environ. Health 53:
     189-204.

Truscott, R. B. (1970) Endotoxin studies in chicks: effect of lead acetate. Can.  J. Comp. Med.
     34:  134-137.

Tschudy, D.  P.; Ebert,  P. S.; Hess,  R.  A.;  Frykholm, B. C.; Weinbach, E.  C. (1980) Effect  of
     heme  depletion  on  growth,  protein synthesis  and respiration  of  murine erythroleukemia
     cells.  Biochem. Pharmacol.  29:  1825-1831.

Tschudy,  D.   P.;  Hess,   R.  A.;  Frykholm,  B.  C.  (1981)  Inhibition  of  6-aminolevulinic acid
     dehydrase by 4,6-dioxoheptanoic acid. J. Biol. Chem. 256: 9915-9923.

Tsoukas, C.  D. ; Provvedini,  D.   M.;  Manolagas,  S.  C.   (1984) 1,25-dihydroxyvitamin D3: a novel
     immunoregulatory hormone. Science (Washington, DC) 224: 1438-1439.

Tsuchiya, K.; Sugita, M.; Sakurai, H. (1978) Dose-response relationships at different exposure
     levels: re-examination in establishing no-effect  levels. Sangyo  Igaku  20: 247-253.

U. S. Centers  for  Disease  Control.  (1978)  Preventing  lead poisoning  in young children:   a
     statement by the Center for Disease Control. J. Pediatr. (St. Louis) 93: 709-720.
                                          12-362

-------
U.  S.  Centers  for  Disease  Control.   (1985)  Preventing  lead  poisoning  in young  children:  A
     statement by the  Centers  of Disease Control, January 1985. Atlanta, GA:  U. S. Department
     of Health and Human Services; no. 99-2230.

U.  S.  Environmental  Protection Agency. (1977) Air quality criteria for lead. Research Triangle
     Park, NC:  Health Effects Research  Lab,  Criteria and Special Studies  Office; EPA report
     no. EPA-600/8-77-017.  Available from:  NTIS, Springfield,  VA; PB-280411.

U.  S.  Environmental   Protection  Agency, Office  of Policy Analysis.  (1984)  Comments on issues
     raised  in the  analysis  of the  neuropsychological  effects  of  low  level  lead exposure,
     presented  by  Hugh  M.   Pitcher.   Presented  at:   Clean  Air  Scientific  Advisory Committee
     (CASAC)  meeting;  April 27.  Available for inspection at:  U.  S. Environmental Protection
     Agency, Central Docket Section, Washington, DC:  docket no.  ECAO-CD-81-2 IIA.F.19.

U.  S.  Health Care Financing Administration.  (1982) 1981 End-stage renal  disease annual report
     to Congress. Washington,  DC:  U.  S. Department  of Health and Human  Services,  Health Care
     Financing Administration; HCFA report no. 82-02144.

Valciukas, J. A.; Lilis, R.  (1980) Psychometric techniques in  environmental research.  Environ.
     Res. 21: 275-297.

Valciukas,  J.  A.;  Lilis,  R.; Eisinger,  J.;  Blumberg, W. E.;  Fischbein, A.;  Selikoff, I.  J.
     (1978)  Behavioral  indicators of  lead neurotoxicity:  results of a clinical  field survey.
     Int. Arch. Occup. Environ.  Health 41: 217-236.

Valentine,  W.  N.;   Paglia,  D.   E.   (1980)  Erythrocyte  disorders  of purine  and  pyrimidine
     metabolism. Hemoglobin 4: 669-681.

Valentine,  W.  N.;  Paglia,  D.  E.;  Fink,  K.;  Madokoro,  G.  (1976) Lead poisoning:  association
     with  hemolytic  anemia,  basophilic  stippling,  erythrocyte  pyrimidine  5'-nucleotidase
     deficiency,  and  intraerythrocytic  accumulation  of pyrimidines.  J. Clin.   Invest.   58:
     926-932.

Valentine,  J.  L.;  Baloh,  R. W.; Browdy,  B.  L.; Gonick, H.  C.; Brown,  C. P.; Spivey, G.  H.;
     Culver,  B. D.  (1982)  Subclinical  effects of chronic increased  lead  absorption—a  pros-
     pective study.  J.  Occup.  Med.  24: 120-125.

Van Assen,  F.  J.   J.  (1958)  Een   geval  van  loodvergiftiging  als  oorzaak van aangeboren
     afwijkingen bij het nageslacht [A case of lead poisoning as cause of congenital anomalies
      in the offspring]?  Ned. Tijdschr. Verloskd.  Gynaecol.  58: 258-263.

Van den  Bergh, A.  A.  H.;  Grotepass, W.  (1933) Porphyrina'mie ohne Porphyrinurie [Porphyrinemia
     without porphyrinuria]. Klin.  Wochenschr. 12: 586-589.

Van Esch, G.  J.; Kroes,  R.  (1969) The induction of renal tumours by feeding basic  lead acetate
      to mice and hamsters.  Br. J. Cancer 23: 765-771.

 Van Esch, G.  J.; Van Genderen, H.; Vink, H. H. (1962) The induction of renal tumors by feeding
      of basic lead acetate to rats. Br. J. Cancer 16: 289-297.

 Vander,  A.  J.; Johnson,  B.  (1981)  Accumulation of  lead  by  renal  slices in the presence of
      organic anions. Proc. Soc. Exp.  Biol. Med. 166:  583-586.
                                            12-363

-------
Vander, A. J. ;  Taylor,  D.  L.;  Kalitis,  K. ;  Mouw,  D. R. ; Victery, W. (1977) Renal handling  of
     lead in dogs:  clearance studies. Am. J. Physiol. 2: F532-F538.

Vander, A. J.; Mouw, D.  R.; Cox, J.; Johnson, B. (1979)  Lead transport by renal slices and its
     inhibition by tin.  Am. J.  Physiol. 236: F373-F378.

Varma,  M.  M. ;  Joshi,   S.  R.;  Adeyemi,  A.  0.  (1974)  Mutagenicity  and  infertility following
     administration of lead sub-acetate to Swiss male mice. Experientia 30: 486-487.

Vasilescu,  C.  (1973)  Motor  nerve  conduction  velocity  and  electromyogram  in  chronic lead
     poisoning. Rev. Roum.  Neurol. 10: 221-226.

Vengris,  V.   E.;  Mare,  C.  J.  (1974)  Lead  poisoning  in chickens and  the effect  of  lead  on
     interferon and antibody production. Can. J. Comp. Med. 38: 328-335.

Verberk, M.  M.  (1976)  Motor nerve conduction velocity in volunteers ingesting inorganic lead
     for 49 days. Int.  Arch. Occup.  Environ. Health  38:  141-143.

Verger,  D.;  Leroux-Robert,  C.;  Ganter, P.;  Richet,  G.  (1967)  Les  tophus  goutteux  de  la
     medullaire renale des uremiques chroniques [Gouty tophus  of  the renal medulary  in chronic
     uremics]. Nephron 4:  356-370.

Verlangieri,  A.  J.  (1979)  Prenatal  and  postnatal  chronic lead intoxication and  running wheel
     activity  in the rat.  Pharmacol. Biochem. Behav. 11: 95-98.

Vermande-Van  Eck,  G.  J. ;  Meigs, J.  W.  (1960)  Changes in  the  ovary  of  the rhesus monkey after
     chronic  lead intoxication. Fertil.  Steril.  11:  223-234.

Victery,  W.;  Vander, A.  J.; Mouw,  D.  R.   (1979a)  Renal  handling  of lead in dogs: stop-flow
     analysis. Am.  J. Physiol.  237:  F408-F414.

Victery, W.;  Vander,  A.  J.; Mouw, D.  R. (1979b) Effect  of acid-base status on  renal excretion
     and accumulation of lead in dogs  and rats.  Am.  J. Physiol. 237:  F398-F407.

Victery, W.;  Soifer,  N.  E.; Weiss,  J.  S.;  Vander, A. J.  (1981)  Acute effects of  lead  on the
     renal handling of zinc  in dogs. Toxicol. Appl.  Pharmacol.  61:  358-367.

Victery, W.;  Vander,  A.  J.; Markel,  H.;  Katzman,  L.; Shulak,  J. M.; Germain,  C.  (1982a)  Lead
     exposure,  begun jn utero, decreases  renin and angiotensin  II  in  adult rats.  Proc. Soc
     Exp. Biol. Med. 170:  63-67.

Victery, W.;  Vander, A. J.;  Shulak,  J. M.;  Schoeps,  P.;  Julius, S.  (1982b) Lead,  hypertension,
     and the  renin-angiotensin system  in rats. J.  Lab. Clin. Med. 99: 354-362.

Victery, W.;  Vander, A. J.;  Schoeps,  P.; Germain,  C.  (1983)  Plasma  renin  is  increased  in young
     rats exposed to lead jji utero and during nursing  (41517).  Proc.  Soc.  Exp.  Biol. Med.  172;


Vigdortchik,  N.  A.  (1935) Lead intoxication in the etiology  of  hypertonia.  J.  Ind. Hyg.  17-
     1-6.

Vitale,  L.  F.;  Joselow,  M.  M. ;  Wedeen, R.  P.;  Pawlow,  M.  (1975) Blood lead—an  inadequate
     measure  of occupational exposure. J. Occup. Med.  17:  155-156.


                                          12-364

-------
Wada, 0.; Yano, Y.; Toyokawa, K.; Suzuki, T.; Suzuki, S.; Katsunuma, H. (1972) Human responses
     to  lead,  in special  references  to porphyrin metabolism  in  bone  marrow erythroid cells,
     and clinical and laboratory study. Ind. Health 10: 84-92.

Wada, 0;  Yano, Y.;  Ono,  T.; Toyokawa,  K.  (1973) The diagnosis  of  different degrees of  lead
     absorption;  in  special  references to choice and evaluation  of various parameters indica-
     tive of an increased lead absorption. Ind. Health 11: 55-67.

Waldron, H.  A.  (1964) The effect of  lead on the  fragility of  the red  cell  incubated i_n vitro.
     J. Clin. Pathol. 17: 405-406.

Waldron, H.  A.  (1966) The anaemia  of lead  poisoning:  a  review.  Br.  J.  Ind.  Med.  23: 83-100.

Walsh,  C.  T. ;  Ryden, E. B.  (1984)  The  effect of  chronic  ingestion of  lead  on gastrointestinal
     transit in rats. Toxicol. Appl.  Pharmacol. 75: 485-495.

Walton,  J.  R.  (1973) Granules  containing  lead  in isolated mitochondria. Nature (London)  243:
     100-101.

Walton,  J.; Buckley,  I.  K. (1977)  The  lead-poisoned  cell:  a  fine structural  study  using
     cultured  kidney cells.  Exp.  Mol.  Pathol. 27:  167-182.

Wapnir,  R.  A.; Moak, S. A.; Lifshitz, F.; Teichberg,  S.  (1979) Alterations  of intestinal and
     renal  functions in rats after intraperitoneal  injections of lead  acetate.  J. Lab.  Clin.
     Med.  94:  144-151.

Wardell,  R. E.;  Seegmiller,  R.  E.; Bradshaw, W.  S.  (1982)  Induction of prenatal  toxicity in
     the  rat  by  diethylstilbestrol,  zeranol,  3,4,3',4',-tetrachlorobiphenyl, cadmium,  and
     lead.  Teratology 26:  229-237.

Watson,  R. J.; Decker,  E.;  Lichtman, H. C.  (1958)  Hematologic  studies of children  with lead
     poisoning.  Pediatrics 21:  40-46.

Watson,  W.  S.;  Hume, R.;  Moore, M.  R. (1980) Oral absorption of  lead and iron.  Lancet 2(8188):
     236-237.

Webb,  R. C.; Winquist,  R.  J.;  Victery, W.;  Vander,  A.  J.  (1981) In vivo and in vitro effects
     of lead on vascular reactivity in rats.  Am.  0.  Physiol.  241: H211-H216.

Wedeen, R. P.  (1981) "Punch cures the gout." J. Med.  Soc. N.  J.  78:  201-206.

Wedeen, R.  P.   (1982) Lead nephrotoxicity.  In:  Porter, G., ed. Nephrotoxic mechanisms of  drugs
      and environmental  toxins.  New York, NY: Plenum Publishing Corp.; pp. 255-265.

Wedeen, R.  P.  (1984)  Poison  in the pot:  the legacy of lead.  Carbondale,  Illinois: Southern
      Illinois  University Press.

Wedeen, R. P.; Maesaka, J. K.;  Weiner, B.; Lipat, G. A.; Lyons,  M. M.; Vitale,  L.  F.; Joselow,
      M. M. (1975) Occupational  lead nephropathy. Am. J.  Med.  59:  630-641.

 Wedeen, R.  P.;  Mallik, D.  K.;  Batuman,  V.;  Bogden, J.  D.  (1978) Geophagic lead  nephropathy:
      case report. Environ.  Res. 17: 409-415.
                                            12-365

-------
Wedeen, R.  P.;  Mallik,  D.  K.; Batuman, V. (1979) Detection and treatment of occupational lead
     nephropathy. Arch.  Intern. Med. 139: 53-57.

Wedeen, R.  P.;  Batuman, V.; Landy,  E.  (1983) The safety  of  the  EDTA lead-mobilization test.
     Environ. Res. 30: 58-62.

Weinreich,  K.;   Stelte,  W.;  Bitsch,  I.  (1977)  Effect of  lead   acetate  on  the  spontaneous
     activity of young rats. Nutr. Metab. 21(suppl.): 201-203.

Weir, P. A.; Mine, C. H. (1970) Effects of various metals  on behavior of conditioned goldfish.
     Arch. Environ. Health 20: 45-51.

Weisburger,  J.  H.; Williams,  G.  M.  (1980)  Chemical  carcinogens.   In:  Doull,  J.;  Klaassen, C.
     D.; Amdur,  M.  0.,  eds.  Toxicology:  the  basic  science of poisons. 2nd  Ed.  New York, NY:
     Macmillan Publishing Co., Inc.; pp. 84-138.

Weller, C.  V.   (1915)  The  blastophthoric effect of  chronic lead  poisoning.  J.  Med.  Res. 33-
     271-293.

Whetsell,  W. 0.,  Jr.;   Kappas,  A.  (1981)  Protective  effect  of  exogenous  heme  against lead
     toxicity in organotypic cultures of mouse dorsal root ganglia  (DRG): electron microscopic
     observations. J. Neuropathol. Exp. Neurol.  40:  334.

Whetsell,  W.  0., Jr.;  Sassa,  S.;  Bickers,  D.;  Kappas,  A.  (1978)  Studies  on porphyrin-herae
     biosynthesis  in organotypic  cultures  of chick dorsal root  ganglion.  I.  Observations on
     neuronal and non-neuronal elements. J.  Neuropathol. Exp. Neurol. 37: 497-507.

Whetsell,  W. 0.,  Jr.; Sassa,  S.;  Kappas, A.  (1984)  Porphyrin-heme  biosynthesis in organotypic
     cultures of mouse dorsal  root  ganglia:  effects of heme  and  lead on porphyrin synthesis
     and peripheral myelin. J. Clin. Invest.  74:  600-607.

White,  D.  J.  (1977) Histochemical and  histological  effects of lead on the liver and kidney of
     the dog. Br. J. Exp. Pathol.  58: 101-112.

White,  J.   M.;  Harvey,  D.  R.  (1972)  Defective  synthesis of  a and p globin chains  in lead
     poisoning.  Nature (London) 236: 71-73.

Wibberley,  D.  G.;  Khera,  A.  K.;  Edwards, J.  H.; Rushton, D. I.   (1977)  Lead levels in  human
     placentae from normal and malformed births.  J.  Med. Genet. 14:  339-345.

Wide,  M.  (1978)  Effect  of inorganic  lead  on  the  mouse  blastocyst in  vitro. Teratology 17-
     165-169.

Wide,  M.   (1980)  Interference  of lead  with  implantation in  the  mouse:  effect  of exogenous
     oestradiol and progesterone.  Teratology  21:  187-191.

Wide,  M.  (1983) Retained developmental capacity of  blastocysts  transferred from lead-intoxi-
     cated mice. Teratology 28: 293-298.

Wide,  M.;  Nilsson,  0.   (1977) Differential  susceptibility of the embryo  to inorganic  lead
     during  peri implantation in the  mouse. Teratology 16:  273-276.
                                          12-366

-------
Wide, M.;  Nilsson,  B.  0.  (1979) Interference  of lead with implantation  in the mouse: a  study
     of  the  surface ultrastructure  of blastocysts  and endometriurn.  Teratology  20: 101-113.

Wide, M.;  Wide, L.  (1980)  Estradiol  receptor activity in uteri of pregnant mice given  lead
     before implantation.  Fertil. Steril. 34:  503-508.

Wiebe, J.  P.;  Barr,  K.  J.;  Buckingham,  K.  D.  (1982) Lead administration during pregnancy and
     lactation  affects steroidogenesis  and  hormone  receptors  in  testes  of  offspring. J.
     Toxicol.  Environ.  Health 10: 653-666.

Wiebe, J.  P.;  Salhanick,  A.  I.; Myers, K. I.  (1983)  On the mechanism  of  action of  lead in the
     testis:  in  vitro  suppression  of FSH receptors,  cyclic AMP and  steroidogenesis.  Life  Sci.
     32: 1997-2005.

Wildt, K.; Eliasson,  R.;  Berlin, M.  (1983)  Effects of occupational exposure  to lead on  sperm
     and  semen.  In: Clarkson,  T.  W.;  Nordberg, G.  F.;  Sager,  P.  R. ,  eds.   Reproductive and
     developmental  toxicity  of  metals  [proceedings  of a  joint meeting;  May  1982;  Rochester,
     NY]. New York, NY: Plenum Press; pp. 279-300.

Willems,  M.  I.;  de  Schepper,   G.  G.; Wibowo,  A.  A.  E.; Immel H.  R.;  Dietrich,  A.  J. J.;
     Zielhuis,  R.  L.  (1982)  Absence  of an  effect of lead acetate  on  sperm morphology,  sister
     chromatid  exchanges  or  on  micronuclei  formation in  rabbits. Arch.  Toxicol.  50: 149-157.

Williams,  B.  J.;  Griffith,  W.   H.;  Albrecht,  C.  M.;  Pirch,  J.  H.;  Hejtmancik,  M. R.,  Jr.;
     Nechay,  B.  R. (1977a) Cardiac  effects  of  chronic lead  poisoning.  In:  Brown,  S. S., ed.
     Clinical  chemistry  and  chemical  toxicology  of  metals.  New  York,  NY:  Elsevier/North-
     Holland Biomedical Press; pp. 127-130.

Williams,  B.  J.; Griffith,  W. H.,  III.;  Albrecht,  C. M.;  Pirch,  J.  H.;  Hejtmancik, M.  R., Jr.
      (1977b)   Effects   of  chronic   lead   treatment  on  some   cardiovascular   responses  to
      norepinephrine  in the rat.  Toxicol.  Appl. Pharmacol.  40: 407-413.

Williamson,  C.  S.  (1920) Gout:  a  clinical  study of one hundred and sixteen cases.  J. Am. Med.
      Assoc. 74:  1625-1629.

Wilson,  V.  K.; Thomson,  M.  L;  Dent, C. E.  (1953)  Amino-aciduria in lead poisoning: a case in
      childhood.  Lancet 2(6776):  66-68.

Wilson,  J. D.;  Simmonds,  H.  A.;  North, J.  D. K.  (1967) Allopurinol  in the treatment  of uraemic
      patients  with gout.  Ann.  Rheum.  Dis.  26:  136-142.

Wince,  L. C.; Donovan, C. A.;  Azzaro, A. J.  (1980) Alterations in the biochemical  properties
      of central dopamine synapses  following  chronic  postnatal  PbC03 exposure.  J.  Pharmacol.
      Exp.  Ther.  214:  642-650.

Windebank, A.  J.;  Dyck,  P.  J.   (1981) Kinetics  of 210Pb entry  into  the endoneurium.  Brain PCS.
      225:  67-73.

Windebank, A.  J.;  McCall, J.  T.;  Hunder, H. G.; Dyck, P. J.  (1980) The  endoneurial content  of
      lead related to the onset and  severity  of segmental demyelination. J.  Neuropathol. Exp.
      Neurol.  39: 692-699.

Winneke, G.  (1980)  Non-recovery of  lead-induced changes  of visual evoked potentials  in rats.
      Toxicol.  Lett. Spec. Iss.   1:  77.

                                           12-367

-------
Winneke, G.;  Kraemer,  U.  (1984) Neuropsychological effects  of  lead in children: interactions
     with social background variables. Neuropsychobiology 11: 195-202.

Winneke,  G.;  Brockhaus,  A.;  Baltissen,  R.  (1977) Neurobehavioral  and systemic  effects of
     longterm  blood  lead-elevation  in  rats.  I.  Discrimination  learning  and open  field-
     behavior. Arch. Toxicol.  37: 247-263.

Winneke, G.;  Hrdina,  K.-G.;  Brockhaus, A.  (1982a) Neuropsychological studies in children with
     elevated  tooth-lead  concentrations.  Part  I.  Pilot  study.   Int.  Arch.  Occup.  Environ
     Health 51: 169-183.

Winneke, G.; Lilienthal, H.; Werner, W. (1982b) Task dependent neurobehavioral effects of lead
     in rats.  Arch. Toxicol. Suppl. 5: 84-93.

Winneke, G. ;  Kramer,  U.;  Brockhaus, A.; Ewers, U.; Kujanek, G.; Lechner, H.; Janke, W. (1983)
     Neuropsychological studies  in children with  elevated tooth-lead concentrations. Part II.
     Extended study. Int.  Arch.  Occup. Environ. Health 51: 231-252.

Winneke,  G. ;  Beginn,  U.;  Ewert,  T. ;  Havestadt,  C.;  Kramer,  U.;  Krause,  C. ;   Thron,  H.  L.;
     Wagner,  H.   M.   (1984)   Studie  zur   Erfassung   subklinischer  Bleiwirkungen  auf  das
     Nervensystem  bei  Kindern mit bekannter pranataler Exposition  in Nordenham  [Study on the
     determination  of  subclinical  lead  effects on the  nervous system  of  Nordenham children
     with  known pre-natal exposure].  Schriftenr.  Ver. Wasser. Boden.  Lufthyg.  (59): 215-229.

Wong, G. L. (1983) Actions of parathyroid hormone  and 1,25-dihydroxycholecalciferol on citrate
     decarboxylation  in  osteoblast-like bone  cells  differ  in  calcium  requirement  and in
     sensitivity to trifluoperazine. Calcif. Tissue Int. 35: 426-431.

Woods,  J.  S. ;  Fowler,  B.  A. (1982)  Selective  inhibition of 6-aminolevulinic acid dehydratase
     by  indium chloride  in rat  kidney:  biochemical  and ultrastructural   studies.  Exp.  Mol
     Pathol. 36: 306-315.

Woolley, D. E.; Woolley-Efigenio, N. D. (1983) Specific dietary components alter the toxicity
     of lead exposure in the postweaning rat.  Proc. West. Pharmacol. Soc. 26: 179-183.

World  Health  Organization,  United  Nations   Environmental  Programme.  (1977)   Lead.  Geneva,
     Switzerland:  World Health Organization. (Environmental  health  criteria 3).

Wyngaarden, J.  B.  (1958)  The role of the kidney in the pathogenesis and treatment of gout. J.
     Am. Rheum. Assoc. 1:  191-203.

Wyrobek,  A.  J.; Bruce, W.  R.   (1978) The  induction of  sperm-shape abnormalities  in mice and
     humans.  In:  Hollaender, A.;  de Serres,  F.   J.,  eds.  Chemical mutagens:  principles and
     methods for their detection: vol. 5. New  York, NY: Plenum Press; pp. 257-285.

Yip,  R.;  Norris,   T.  N.;  Anderson,  A.  S.  (1981)  Iron status of  children with  elevated blood
     lead concentrations.  J. Pediatr. (St.  Louis)  98:  922-925.

Youroukos,  S. ;  Lyberatos,  C. ;  Philippidou,  A.; Gardikas, C.; Tsomi, A.  (1978)  Increased blood
     lead  levels  in mentally  retarded children  in Greece.  Arch.  Environ.   Health 33: 297-300.

Yii,  T.-F.  (1982)   Clinical  aspects of  nephropathy in gout  and  hyperuricemic states. In: YU,
     T.-F.;  Berger, L. ,  eds.   The kidney  in  gout and  hyperuricemia.  Mt.   Kisco,  NY:  Futura
     Publishing Co.; pp. 261-292.

                                          12-368

-------
YU, T.-F.;  Berger,  L.  (1982)  Impaired renal  function in  gout:  its  association  with hyper-
     tensive vascular disease and intrinsic renal disease. Am. J.  Med. 72: 95-100.

Yule,  W.;  Lansdown,  R.  (1983)  Lead  and  children's  development:  recent  findings.  In:
     International conference:  heavy  metals  in the environment:  v.  2; September;  Heidelberg,
     West Germany. Edinburgh, United Kingdom: CEP Consultants, Ltd.; pp. 912-916.

Yule, W.; Lansdown, R.; Millar, I. B.; Urbanowicz, M.-A.  (1981) The relationship between blood
     lead concentrations,  intelligence and attainment  in a school  population:  a pilot study.
     Dev. Med. Child Neurol. 23: 567-576.

Yule,  W.;  Urbanowicz,  M.-A.;  Lansdown,  R.;   Millar,  I.  B.  (1984)  Teachers'   ratings   of
     children's behaviour  in relation to  blood  lead  levels.   Br. J.  Dev.  Psychol.  2:  295-305.

Zawirska, B.;  Medras,  K.  (1968) Tumoren  und  Storungen des Porphyrinstoffwechsels bei Ratten
     mit  chrpnischer experimenteller  Bleiintoxikation.  I.  Morphologische Studien  [Tumors and
     porphyrin  metabolism   disturbances   in   rats  with  experimental  lead  intoxication.   I.
     Morphological studies]. Zentralbl. Allg.  Pathol.  Pathol.  Anat.  Ill:  1-12.

Zawirska, B.;  Medras, K. (1972) The  role of the kidneys  in disorders of porphyrin metabolism
     during  carcinogenesis  induced with  lead  acetate.  Arch. Immunol. Ther.  Exp.  20:  257-272.

Zegarska, Z.;  Kilkowska, K.; Romankiewicz-Wdzniczko,  G.  (1974)  Developmental defects  in white
     rats caused  by  acute  lead  poisoning.  Folia  Morphol.  (Warsaw) 33:  23-28.

Zeigler,  H.  P. (1973)  The  problem of comparison in  comparative  psychology.  Ann.   N.  Y. Acad.
     Sci. 223: 126-134.

Zel'tser,  M.  E.   (1962) K  voprosu  o funktsional'nom sostoyanii  shchitovidnoi  zhelezy  pri
     caturnizme  (predvarital'noe soobshchenie)  [The  functional  state of  the thyroid  gland  in
     lead poisoning]. Tr.  Inst.  Kraev. Patol.  Akad.  Nauk Kaz.  SSR 10: 116-120.

Zenick,  H.;  Padich,  R.; Tokarek,  T.; Aragon,  P.  (1978) Influence  of  prenatal and postnatal
     lead exposure on  discrimination  learning in rats. Pharmacol.  Biochem.  Behav.  8:  347-350.

Zenick,  H.;  Pecorraro, F.; Price,  D.;  Saez,  K.;  Ward, J.  (1979)  Maternal  behavior  during
     chronic  lead  exposure  and measures  of offspring  development. Neurobehav.   Toxicol.  1:
     65-71.

Zielhuis, R.  L.; Wibowo,  A.  A.  E.  (1976)  Review paper:  susceptibility of adult females to
      lead:  effects  on  reproductive  function  in females  and males.  Presented at:  2nd inter-
      national workshop:  permissible limits  for  occupational   exposure  to lead;  September;
      Amsterdam,  The Netherlands.

 Zielhuis, R.  L.;  del  Castilho, P.; Herber, R.  F.  M. ; Wibowo, A. A.  E.  (1978a) Levels of lead
      and other metals  in  human blood: suggestive relationships, determining factors. Environ.
      Health Perspect. 25:  103-109.

 Zielhuis,  R.  L.; Wibowo,  A.  A. E.;  Irwig,  L.  M.;  Harrison, W.  0.; Webster, I.; Andrew,  M.
      (1978b) Lead and morbidity [letter]. Lancet 2(8088):  532-533.

 Zimering,  R.  T.; Burright, R. G.;  Donovick,  P. J.  (1982)  Effects of pre-natal and  continued
      lead  exposure  on  activity  levels  in  the  mouse.  Neurobehav.  Toxicol.  Teratol. 4:  9-14.


                                           12-369

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Zimmermann-Tansella, C.; Campara, P.; D'Andrea, F.; Savonitto, C.; Tansella, M. (1983) Psycho-
     logical and physical  complaints of subjects with  low exposure to lead. Hum. Toxicol. 2:
     615-623.

Zollinger, H. U.  (1953)  Durch chronische Bleivergiftung erzeugte Nierenadenome und -carcinome
     bei Ratten und ihre Beziehungen zu den  entsprechenden Neubildungen des Menschen [Kidney
     adenomas and  carcinomas  in rats caused  by  chronic lead poisoning and their relationship
     to corresponding  human neoplasms].  Virchows Arch. Pathol. Anat.  Physiol.  323:  694-710.

Zook,  B.  C. ; London,  W.  T.;  DiMaggio,  J.  F.;  Rothblat,   L.  A.;  Sauer, R.  M.;  Sever,  J. L.
     (1980)  Experimental  lead paint  poisoning in nonhuman primates.  II.  Clinical pathologic
     findings and behavioral effects. J. Med.  Primatol. 9:  286-303.
                                           12-370

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                     APPENDIX 12-A

SUMMARY OF PSYCHOMETRIC TESTS USED TO ASSESS COGNITIVE
  AND BEHAVIORAL DEVELOPMENT IN PEDIATRIC POPULATIONS
                      12A-1

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                                         TABLE 12A.  TESTS COMMONLY USED IN A PSYCHO-EDUCATIONAL BATTERY FOR CHILDREN
                                   Age range
                                                     Noras
                                           Scores
                                                                          Advantages
                                                                                    Disadvantages
General Intelligence Tests

Stanford-Binet (form L-H)
2 yrs - Adult       1972
Wechsler Preschool & Primary      4 - 6% yrs          1967
  Scales of Intelligence (WPPSI)  Best for 5-yr-olds
Wechsler Intelligence Scale       6-16 yrs
  for Children-Revised (WISC-R)
 PO
McCarthy Scales of Children's
  Abilities (MSCA)
ft - Wi yrs
Best for ages
4-6
                    1974
1972
Bayley Scales of Mental
Development
2-30 mos.
1969
                                   1. Deviation IQ:
                                      Mean = 100 SD = 16
                                   2. Mental Age Equivalent
                                   1. Deviation IQ:
                                      Mean = 100 SD = IS
                                   2. Scaled Scores for
                                      10 sub tests:
                                      Mean = 10 SO = 3
                                   1. Deviation IQ:
                                      Mean = 100 SD = IS
                                   2. Scaled Scores for
                                      10 subtests: Mean = 10
                                      SD= 3
1.  General Cognitive Index:
   Mean = 100 SD = 16
2.  Scaled scores for 5
   subtests: wan = SO
   SD = 10 Age equivalents
   can be derived.
                                   1.  Standard scores
                                       (H = 100 SO = 16)
                                   2.  Mental Development
                                       PsychoMotor Index
                                            1.  Good reliability & validity
                                            2.  Predicts school  performance
                                            3.  Covers a wide age range
                                                                1. Good reliability & validity
                                                                2. Predicts school performance
                                                                3. Gives a profile of verbal &
                                                                   non-verbal skills.
                                                                4. Useful in early identifica-
                                                                   tion of learning disability

                                                                1. Good reliability & validity
                                                                2. Predicts school performance
                                                                3. Gives a profile of verbal
                                                                   and non-verbal skills
                                                                4. Useful in identification of
                                                                   learning disability

                                                                1. Good reliability & validity
                                                                2. Good predictor of school
                                                                   performance
                                                                3. Useful in identification of
                                                                   learning disabilities when
                                                                   given with a WISC-R or
                                                                   Stanford-Binet
                                                                4. Gives good information for
                                                                   educational programming

                                                                1.  Norms are excellent
                                                                2.  Satisfactory reliability
                                                                    and validity
                                                                3.  Best measure of infant
                                                                    development
                                                             1.  Tests  mostly  verbal  skills
                                                                especially  after  6 yrs
                                                             2.  Does not give a profile
                                                                of skills

                                                             1.  Narrow age  range
                                                             2.  Mentally retarded children
                                                                find this a disproportionately
                                                                difficult test
                                                                            1.  Gives a lower IQ than
                                                                               Stanford-Binet for normal
                                                                               and bright children
1. Children score much lower
   than on WISC-R or
   Stanford-Binet
2. Narrow age range
                                                             1.   Not a good predictor of
                                                                 later functioning in
                                                                 average as in below average
                                                                 children

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                                                                       TABLE 12A.  (continued)
                                      Age range
                                                        Norms
                                                                                Scores
                                                                           Advantages
                                                                                      Disadvantages
   Slosson Intelligence Test
 Infancy -  27 yrs    1963
                1.  Ratio IQ:  is not
                   related to general
                   population
   Peabody Picture Vocabulary
     Test
2>s - 18 yrs
 1959,rev.1981   1.  Verbal  IQ
 White,          2.  Age equivalent
 Middle class
 sample
(__ Visual-Hotor Tests
r\j
:> Frostig  Developmental  Test of

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                                                                    TABLE 12A.   (continued)
                                   Age  range
                                                      Horns
                                                                             Scores
                                                                          Advantages
                                                                                     Disadvantages
Educational Tests

Wide Range Achievement  Test
  (WRAT)
Peabody Individual
  Achievement Test (PIAT)
5 yrs - Adult
5-18 yrs
1976
Revised
1969
-fc.
Woodcock Reading
  Mastery Tests
Spache Diagnostic
   Reading Scales
Key Hath Diagnostic
  Arithmetic Test
Kgn - 12 grade
1st - 8th grade
1971-72
adjusted for
social class
1972
Pre-school - 6th
grade
                                                       1971
1. Standard Score:
   •ean = 100 SO = 15
Z. Grade equivalent
               1. Standard Scores:
                  Mean = 100 SD = 15
               2. Grade equivalent
               3. Age equivalent
1. Grade equivalent
2. Standard Score
3. Percent!le Rank
1. Instructional level of
   reading (grade equiva-
   lent).
2. Independent  level of
   reading.
3. Potential level of
   reading

1. Grade equivalent
1. Good reliability & validity
   Reading scores predict
   grade level
2. Tasks similar to actual
   work
1. Reading portion tests
   word recognition only
2. Responses require good
   organizational skills
   (could be an advantage)
                             1. Tests word recognition and   1.
                             2. Breaks down skills into 5
                                areas                        2.
1. Good reliability
2. Breakdown of reading skills
   useful diagnostically and in
   planning remediation
3. Easy to administer and score
                                                                                                   2.
   Independent level score
   predicts gains following
   remediation
   Good breakdown of reading
   skills
                                               Excellent breakdown  of math
                                               skill*
                                               Easy to administer and
                                               score
   Moderate reliability. Low
   stability for Kindergarten
   No data on predictive
   validity
   A multiple choice test
   requiring child to recog-
   nize correct answer  (could
   be an advantage).
   Heavily loaded on verbal
   reasoning.
   Factor structure changes
   with age.

   No data on validity
   Fairly complex scoring
   Moderate reliability
                                                                                                                                   3. No good data on validity
                                 1. Moderate reliability
                                 2. No data on validity

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                                                                     TABLE 12A.   (continued)
                                    Age  range
                                                      Nor
                                                                              Scores
                                                                           Advantages
                                                                                      Disadvantages
 Tests of Adaptive functioning
 Vineland Social  Maturity  Scale    Birth  -  25 yrs
AAHD Adaptive Behavior Scale      3 yrs  - Adult
                    1983            1. Social Quotient  (Ratio)
                    Revised         2. Social Age  Equivalent
                    1974
                    Institu-
                    tionalized
                    Retardates;
                    Public School
                    Children (1982)
               1. Percent!le Ranks
               2. Scaled scores
Progress Assessment Chart of
  Social Development (PAC)
Developmental Profile
Conners Rating Scale
                                  Birth - Adult
Birth - 12 yrs
3 yrs - 17 yrs
                    1976
1972
1978
                                   No Scores
1. Age equivalents in 5
   5 areas
2. IQ equivalency (IQE)
1.  Age equivalents
                                             1.  Easily  administered
                                             2.  Good  reliability  for  normal
                                                and MR  chidren
                             1. Diserial nates between  EMR
                                and regular classes
                             2. Useful for class placement
                                and Monitoring progress
1. Useful for training and
   assessing progress
2. Gives profile of skills

1. Good reliability and valid-
   ity.  Excellent study of
   construct validity reported
   in Manual.
2. Gives a profile of skills

1. Most widely used Measure of
   attention deficit disorder
2. Four factors: conduct prob-
   lems; hyperactivity;
   inattentive-passive; hyper-
   activity index
1. Poor norms
2. No data on validity
3. Items are limited past
   preschool years
4. Scores decrease with age
   for MR children

1. Moderate reliability for
   independent living skills
   scale.  Poor reliability
   for ma1adaptive behaviour
   scale.
2. Lengthy administration
3. Items & scoring are not
   behaviorally objective

1. No data on reliability or
   validity


1. IQE underestimates IQ of
   above average children,
   overestimates IQ of below
   average chiIdren.
   Parents'  ratings don't pre-
   dict as well as teachers'
   ratings
   Works best Middle class
   children
Werry-Weiss-Peters Hyperactivity   1  yr  -  9 yrs
  Scale
                    1974, 1977     1. Age equivalents
                                             1. Good measure of  hyperac-
                                               tivity
                                             2. Seven Factors
                                                             1. Limited age range
                                                             2. Standardized on Middle
                                                                class children

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                     13.   EVALUATION  OF  HUMAN  HEALTH  RISKS  ASSOCIATED WITH
                              EXPOSURE TO LEAD AND  ITS COMPOUNDS
13.1  INTRODUCTION
     This chapter attempts  to  integrate,  concisely,  key information and conclusions  discussed
in preceding chapters  into  a coherent framework by which  interpretation  and judgments  can be
made concerning the  risk  to human health posed by present levels of lead contamination  in the
United States.
     Towards this end,  the  chapter is organized  into  eight  sections,  each of which  discusses
one or more  of the following major components of the overall health risk evaluation:   (1) ex-
ternal and  internal  exposure aspects of lead; (2) lead metabolism, which determines  the rela-
tionship  of  external  lead exposure to associated  health  effects of lead; (3) qualitative and
quantitative characterization of key health effects of lead; and (4) identification of popula-
tion groups at special  risk  for health effects associated with lead exposure.
     The  various aspects  of  lead exposure discussed include:  (1) an historical perspective on
the  input of  lead  into the environment as  well  as the nature  and magnitude of current lead
input; (2)  the cycling of  lead through the various environmental compartments; and (3) levels
of  lead  in those media most relevant to lead exposure of various segments of the U.S. popula-
tion.  These various aspects of lead exposure are  summarized in  Section 13.2.
      In  regard to  lead metabolism, some  of the  relevant  issues addressed include:   (1) the
major  quantitative  characteristics of lead  absorption, distribution,  retention, and excretion
in  humans and how  these  differ between adults and  children;  (2) the toxicokinetic  bases for
external/internal  lead exposure  relationships  with  respect  to both  internal  indicators and
target tissue  lead  burdens;  and (3)  the  relationships  between  internal  and external indices of
lead  exposure, i.e.,  blood  lead levels,  and  lead  concentrations  in  air,  food, water,  and  dust/
soil.   Section 13.3 summarizes the  most salient  features of lead  metabolism, whereas  Section
13.4  addresses experimental and  epidemiological  data concerning  various blood lead-environ-
mental media lead relationships.
      In  discussion of  the  various  health  effects of lead,  the  main emphasis is  on the  identi-
 fication of those effects most relevant to various segments of the general  U.S.  population and
 the placement of such effects in  a dose-effect/dose-response framework.  With regard  to the
 latter,  a crucial issue has to do with relative response  of various segments of  the  population
 in terms of observed  effect levels as indexed by some exposure indicator.   Furthermore, it is
 of interest to  assess the  extent to which  available information  supports  the  existence of  a
 continuum of  effects as one proceeds  across  the spectrum of  exposure  levels.   Discussion of
                                            13-1

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data on the  relative  number or percentage of members (i.e.,  "responders")  of specific  popula-
tion groups  that  can  be expected to experience  a  particular effect at various  lead exposure
levels  is  also  important   in  order to  permit  delineation  of  dose-response  curves  for  the
relevant effects  in different  segments  of  the  population.   These  matters  are discussed  in
Sections 13.5 and 13.6.
     Melding of  information from the  sections on  lead exposure, metabolism,  and  biological
effects permits the identification  of  population segments at special risk  in terms  of  physio-
logical and other host characteristics, as well as  heightened vulnerability to a given  effect;
these risk groups  are  discussed in Section  13.7.  With demographic  identification  of  indivi-
duals at risk,  one may then draw upon population data from other sources to obtain a numerical
picture of the  magnitude  of population groups at  potential  risk.   This is  also  discussed  in
Section 13.7.
     Section  13.8  summarizes   key  information  and  conclusions  derived  from  the analyses
presented in the preceeding sections.
13.2  EXPOSURE ASPECTS
13.2.1  Sources of Lead Emission in the United States
     The most  important issues addressed  here concerning  the sources  of  lead in  the  human
environment are:  What  additional  pathways of human consumption have been added in the course
of civilization?  What are the relative contributions of natural and anthropogenic lead?   From
the  available  data,  what trends  can  be  expected  in  the potential  consumption of  lead  by
humans?  What  is  the impact of normal  lead  cycling processes on total  human  exposure?   And,
finally, are  there population segments particularly  at risk  due to a  higher-potential  expo-
sure?
     Figure  13-1  is  a  composite  of  similar figures appearing in  Chapters  7 and  11.   This
figure  shows that  four  of the five sources  of lead in the human environment are of anthropo-
genic  origin.   The  only significant  natural  source is from  the  geochemical weathering  of
parent  rock material as an input to soils.   Of the four anthropogenic pathways, two are close-
ly  associated  with  atmospheric emissions  and  two (pigments  and  solder)  are more directly
related to the use of metallurgical compounds in products consumed by humans.
     It is clear  that natural sources contribute only  a very small fraction to total lead in
the  biosphere.   Levels of  lead in the  atmosphere, the  main conduit  for  lead movement from
sources  into various  environmental  compartments,  are  10,000  to  20,000-fold  higher  in some
urban  areas  than in  the most  remote  regions of the earth.   Chronological  records assembled
                                           13-2

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     INDUSTRIAL
      EMISSIONS
  CRUSTAL
WEATHERING
                                               SURFACE AND
                                              GROUND WATER
                   FECES  URINE
Figure 13-1. Pathways of laad from the environment to man, main
compartments involved in  partitioning of internal  body burden of
absorbed/retained lead, and main routes of leed excretion.
                          13-3

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using reliable lead analysis techniques show that atmospheric lead levels were at least  2,000-
fold  lower  than  at present before  abrupt anthropological  inputs accelerated with the  indus-
trial revolution  and,  more recently,  with the  introduction of leaded  gasoline.  For  actual
comparison,  estimates indicate a  general  background air lead level  of 0.00005-0.0005  ug Pb/m3
versus current urban  air lead concentrations  frequently approaching 1.0 ug  Pb/m3.   A  recent
measurement of 0.000076 ug  Pb/m3  at the South Pole, using highly reliable lead analyses, sug-
gests an anthropogenic enrichment factor  of 13,000-fold compared to  the same urban air level
of 1.0 ug Pb/m3.
     Lead occupies an important  niche  in the U.S.  economy,  with consumption averaging  1.28 x
106 metric tons/year over the period 1971-1984.     Of  the  various  categories of lead  consump-
tion, those of pigments,  gasoline additives,  ammunition, foil,  solder, and steel products are
widely dispersed  and  therefore unrecoverable.   In the  United  States,  about  39,000  tons are
emitted to  the  atmosphere each year,  including  35,000 tons as gasoline  additives.   Lead and
its compounds enter the  atmosphere at various  points during mining,  smelting, processing, use,
recycling,  or disposal.   Leaded  gasoline  combustion  in vehicles accounted  for  90 percent of
the total  anthropogenic  input into the  atmosphere in the United States in 1984; of the remain-
ing 10 percent of total  emissions  from  stationary sources,  5 percent was from the metallurgical
industry,  3 percent was  from waste combustion, 1  percent from combustion during energy produc-
tion, and  1  percent  was from miscellaneous sources.   Atmospheric emissions  have  declined in
recent years  with the  phase-down of lead in gasoline.
     The fate of emitted particulate  lead depends  on particle size.   It  has  been estimated
that, of the  75  percent of combusted  gasoline lead which immediately departs  the vehicle in
exhaust,  46  percent  is in  the form of particles  <0.25 urn mass median aerodynamic  diameter
(MMAD) and  54 percent has  an average particle  size  >10 urn.  The sub-micron  fraction  is in-
volved in long-range transport, whereas the larger particles settle  mainly near the  roadway.

13.2.2  Environmental  Cycling of Lead
     The atmosphere is  the  main conduit  for  movement  of lead from emission  sources  to other
environmental compartments.   Removal  of  lead from  the atmosphere  occurs by both wet and dry
deposition processes, each  mechanism  accounting for  about  one-half of  the atmospheric lead
removed.   The fraction of  lead emitted as alkyl  lead vapor (1-6 percent) undergoes subsequent
transformation to other, more stable compounds such as  triethyl-  or trimethyl lead as  a com-
plex function of  sunlight,  temperature, and ozone level.
     Studies of the movement of lead emitted into the atmosphere indicate that air lead levels
decrease logarithmically with distance away from the  source:   (1)  along gradients from emis-
sion sites, e.g.,  roadways  and smelters;  (2) within  urban  regions  away from central  business
districts;  (3) from urban to rural areas;  and (4) from developed to remote areas.
                                           13-4

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     By means of wet  and  dry deposition, atmospheric lead  is  transferred to terrestrial  sur-
faces and bodies of water.   Transfer to water  occurs  either directly from  the  atmosphere  or
through runoff from soil  to surface waters.   A sizeable  fraction  of water-borne lead becomes
lodged in aquatic sediments.   Percolation  of water through  soil does  not transport much  lead
to ground water because most of the lead is retained at the soil  surface.
     The  fate  of  lead particles  on terrestrial  surfaces  depends  upon  such factors as  the
mechanism of deposition, the chemical form of the particulate lead, the chemical  nature of the
receiving soil,  and the  amount of  vegetation  cover.   Lead deposited on  soils  is  apparently
immobilized  by  binding to  humic  or fulvic  acids, or  by ion exchange  on  clays and hydrous
oxides.  In  industrial, playground,  and household environments,  atmospheric particles accumu-
late as  dusts  with  lead concentrations often greater than 1000 ug/g.  It is important to  dis-
tinguish  these  dusts  from  windblown soil dust,  which typically  has  a  lead concentration  of
10-30 ug/g.
     It  has  been estimated  that soils adjacent to roadways  have been enriched in lead content
by as much as 10,000 ug/g soil since 1930, while in urban areas and  sites adjacent to smelters
as much as 130,000 ug/g has been measured in the upper 2-5 cm layer  of soil.
     Soil appears  to  be  the major  sink  for emitted lead,  with a residency half-time of de-
cades; however, soil as a reservoir  for lead cannot be considered  as an infinite sink, because
lead will continue to  pass  into the  grazing  and detrital  food chains and  sustain elevated lead
levels  in them until  equilibrium  is reached.   It was estimated in Chapters  7 and 8 that soils
not  adjacent to  major sources  such  as highways and smelters contain 3-5  ug/g of anthropogenic
lead,  and that this lead has  caused an increase of lead in soil  moisture by a  factor of 2-4.
Thus,  movement of  lead from  soils to other environmental  compartments  is  at least twice the
prehistoric  rate and will continue to increase  for the  foreseeable future.
     Lead enters  the  aquatic  compartment  by direct transfer  from the atmosphere via wet and
dry  deposition,  as well  as  indirectly  from the  terrestrial  compartment via surface runoff.
Water-borne  lead,  in turn,  may be retained  in  some soluble  fraction or may  undergo  sedimenta-
tion,  depending on such  factors  as pH, temperature, suspended matter which may entrap  lead,
etc.   Present levels of  lead  in natural waters represent a  50-fold  enrichment over  background
content,  from  0.02  to  1.0 pg/1, due  to  anthropogenic activity.  Surface waters receiving  urban
effluent represent  a  2500-fold and higher  enrichment (50  ug Pb/1 and higher).

13.2.3   Levels of  Lead in Various  Media of Relevance to Human  Exposure
      Human  populations in the United States  are exposed to lead  in air,  food, water, and  dust.
In  rural  areas, Americans not occupationally exposed to lead are  estimated to consume 40-60 ug
Pb/day.   This  level   of  exposure  is referred  to as  the baseline  exposure for the American
population  because  it is  unavoidable except  by  drastic change in  lifestyle or by regulation of
                                            13-5

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lead in foods or ambient air.   There are several  environmental  circumstances  that  can  increase
human exposures above baseline  levels.   Most of these circumstances  involve  the  accumulation
of atmospheric dusts in  the  work and play environments.   A  few,  such as  pica and family  home
gardening, may  involve  consumption of  lead in chips  of exterior or interior house  paint.
13.2.3.1   Ambient Air Lead Levels.   Monitored ambient  air lead  concentration  values in  the
United States are contained in two principal  data bases:   (1)  EPA's National  Air Sampling  Net-
work (NASN), recently renamed National  Filter Analysis  Network (NFAN); and (2) EPA's  National
Aerometric Data  Bank,  consisting of measurements  by state and local  agencies  in  conjunction
with compliance monitoring for the current ambient air lead standard.
     NASN  data  for  1982, the latest year  in the annual  surveys  for  which valid  distinctions
can be made between urban and non-urban stations, indicate that most urban sites show  reported
annual  averages  below  0.7 ug Pb/m3, while  the  majority  of  non-urban locations  have  annual
figures below-0.2 ug Pb/m3.   Over the  interval  1976-1984,  there  has  been a  downward  trend in
these  averages,  mainly  attributable  to decreasing  lead  content  of  leaded  gasoline  and  the
increasing usage of lead-free gasoline.   Furthermore, examination of quarterly averages  over
this interval shows a  typical seasonal variation,  characterized by maximum air lead values in
summer and minimum values in winter.
     With  respect  to  the  particle  size distribution of  ambient air  lead,  EPA studies  using
cascade impactors in six U.S. cities have indicated  that 60-75 percent of such  air  lead was
associated with  sub-micron particles.   This size distribution is  significant  in considering
the  distance  particles  may  be  transported  and  the deposition of particles  in the pulmonary
compartment of  the  respiratory  tract.   The relationship between airborne lead at  the  monitor-
ing station and the lead inhaled by humans is complicated by such variables as vertical  gradi-
ents,  relative  positions of  the source, the  monitor, and the person, and the ratio of indoor
to outdoor lead concentrations.   Personal  monitors would probably be the most effective means
to obtain  an accurate picture of the amount of lead inhaled during the normal activities of an
individual.  However, the  information  gained would be insignificant, considering that inhaled
lead  is generally  only  a small  fraction of  the  total lead exposure,  compared  to the lead in
food,  beverages, and dust.   The critical question in regard to airborne lead is how much lead
becomes entrained  in dust.   In  this respect, the existing monitoring network may provide an
adequate  estimate  of the  air concentration  from  which the rate  of  deposition can be deter-
mined.
13.2.3.2   Levels of Lead In  Dust.   The  lead content of  dusts can figure prominently  in the
total  lead exposure  picture  for young children.   Lead in aerosol particles deposited on rigid
surfaces   in urban  areas  (such as  sidewalks,  porches,   steps,  parking lots,  etc.)  does not
undergo  dilution compared to lead  transferred  by deposition  onto  soils.    Lead  in  dust can

                                           13-6

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approach extremely  high concentrations and  can accumulate  in  the interiors of dwellings  as
well as in the outside surroundings,  particularly in urban areas.
     Measurements of  soil  lead  to a  depth of 5 cm in areas of the United States were shown  in
one study to  range  from 150 to 500 ug/g dry weight close to roadways (i.e.,  within 8 meters).
By  contrast,  lead  in dusts deposited on or near heavily traveled traffic arteries  show levels
in  major U.S.  cities ranging up to 8000 ug/g and higher.  In residential areas, exterior dust
lead  levels  are approximately  1000  ug/g  or  less  if  contaminated only by  atmospheric  lead.
Levels of lead in  house dust can  be  significantly elevated; a study of house dust samples  in
Boston  and  New  York City  revealed  levels of 1000-2000 ug/g.  Some  soils adjacent to houses
with exterior  lead-based paints may have lead concentrations greater than 10,000 ug/g.
     Forty-four  percent of the baseline consumption of  lead  by children  is estimated to result
from consumption of  0.1 g of dust per day  (Tables 13-1  and 13-2).  Ninety percent of this dust
lead  is of atmospheric origin.   Dust  also accounts for more than 90 percent of the additive
lead attributable to living  in an  urban environment or  near  a smelter  (Table  13-3).
13.2.3.3  Levels of  Lead in  Food.  The route by which  adults  and older children in the base-
line  population of the United States  receive  the  largest  proportion  of  lead  intake  is through
foods,  with  reported estimates of the  dietary lead intake for Americans ranging from  35 to 55
ug/day.   The  added  exposure from  living  in  an urban  environment  is  about 28  HQ/day for adults
and 91 ug/day for children,  all of which  can  be attributed to atmospheric lead.
      Atmospheric lead may  be added  to  food crops  in  the  field  or pasture,  during  transporta-
tion  to the market,  during  processing, and during kitchen preparation.  Metallic  lead, mainly
 solder,  may be  added during processing and packaging.   Other sources of lead,  as yet undeter-
mined, increase the  lead  content of food between  the  field and dinner table.   American chil-
 dren,  adult females, and  adult males  consume  21,  32,  and 45 ug Pb/day, respectively, in food
 and beverages.  Of  these  amounts, 45-65  percent  is  of direct atmospheric origin,  25-37 per-
 cent  is of  metallic origin,  and 5-8  percent is of undetermined origin.
      Processing of foods,  particularly canning, can significantly add to their background  lead
 content, although  it appears  that  the impact  of  this is being  lessened with  the trend  away
 from  use  of   lead-soldered  cans.   The canning process can increase  lead levels  8-to 10-fold
 higher  than  for the corresponding uncanned  food  items.   Home  food preparation can  also  be a
 source  of  additional  lead  in  cases where  food preparation surfaces  are exposed to moderate
 amounts of high-lead household dust.
 13.2.3.4  Lead  Levels  in Drinking Water.   Lead  in  drinking  water  may  result  from contamination
 of the  water source or from the use of lead materials  in the water  distribution system.   Lead
 entry  into  drinking water  from  the  latter is increased in water  supplies which are plumbo-
 solvent, i.e.,  with a pH  below  6.5.   Exposure of individuals occurs  through  direct  ingestion
 of the water  or via food preparation  in such  water.
                                            13-7

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                                TABLE 13-1.   SUMMARY OF  BASELINE  HUMAN  EXPOSURES TO  LEAD
                                                        (ug/day)
I
00
Source
Child-2 yr old
Inhaled air
Food, Water &
beverages
Dust
Total
Percent
Adult female
Inhaled air
Food, Water &
beverages
Oust
Total
Percent
Adult male
Inhaled air
Food, Water &
beverages
Dust
Total
Percent
Total
lead
consumed

0.5

25.1
21.0
46.6
100%

1.0

32.0
4.5
37.5
100%

1,0

45.2
4.5
50.7
100%
Soil
Natural
lead
consumed

0.001

0.71
0.6
1.3
2.8%

0.002

0.91
0.2
1.2
3.1%

0.002

1.42
0.2
1.6
3.1%
Indirect
atmospheric
lead*

-

1.7
-
1.7
3.5%

-

2.4
	 _
2.5
6.6%

-

3.5
-
3.5
6.8%
Direct
atmospheric
lead*

0.5

10.3
19.0
29.8
64.0%

1.0

12.6
2.9
17.4
46.5%

1.0

19.3
2.9
23.2
45.8%
Lead from
solder or
other metals

-

11.2
-
11.2
24.0%

-

8.2
-
13.5
36.1%

-

18.9
-
18.9
37.2%
Lead of
undetermined
origin

-

1.2
1.4
2.6
5.6%

-

1.5
.1.4
2.9
7.8%

-

2.2
1.4
3.6
7.0%
       *Indirect  atmospheric  lead  has  been  previously incorporated  into  soil,  and  will  probably  remain  in the
        soil  for  decades or  longer.  Direct atmospheric  lead has  been  deposited on the  surfaces  of  vegetation
        and living  areas or  incorporated during  food  processing prior  to human consumption.

       Source:  This  report.

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    TABLE 13-2.  RELATIVE BASELINE HUMAN LEAD EXPOSURES EXPRESSED PER KILOGRAM BODY WEIGHT*

Child (2-yr-old)
Inhaled air
Food and beverages
Dust
Total
Adult female
Inhaled air
Food and beverages
Dust
Total
Adult male
Inhaled air
Food and beverages
Dust
Total
Total
lead
consumed,
ug/day
0.5
25.1
21.0
46.6
1.0
32.0
4.5
37.5
1.0
45.2
4.5
50.7
Total lead consumed
per kg body wt,
ug/kg'day
0.05
2.5
2.1
4.65
0.02
0.64
0.09
0.75
0.014
0.65
0.064
0.73
Atmospheric lead
per kg body wt,
ug/kg-day
0.05
1.0
1.9
2.95
0.02
0.25
0.06
0.33
0.014
0.28
OJD4_
0.334
*Body weights:   2-year-old child = 10 kg; adult female = 50 kg; adult male = 70 kg.
Source:   This report.

     The major  source  of lead contamination of drinking  water is the distribution system it-
self, particularly  in  older urban areas.  Highest levels are encountered in "first-draw" sam-
ples, i.e.,  water  sitting  in the piping system  for  an extended period of time.   In  a large
community water  supply survey of 969 systems  carried out in 1969-1970, it was found that the
prevalence of samples exceeding 0.05 ug/g was greater where water was plumbo-solvent.
     Most  drinking water,  and  the  beverages  produced  from  drinking water,  contain 0.007-
0.011 ug  Pb/g.    The  exceptions are  canned juices and soda pop, which  range from 0.018 to
0.040 ug/g.   About 15 percent of the  lead consumed in drinking water  and  beverages  is of
direct atmospheric  origin;  60 percent comes from  solder and other metals.
                                            13-9

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             TABLE 13-3.   SUMMARY OF POTENTIAL ADDITIVE EXPOSURES  TO  LEAD  (pg/day)




Baseline exposure:
Child
Inhaled air
Food, water & beverages
Dust
Total baseline
Additional exposure due to:
Urban atmospheres1
Family gardens2
Interior lead paint3
Residence near smelter4
Secondary occupational5
Baseline exposure:
Adult male
Inhaled air
Food, water & beverages
Dust
Total baseline
Additional exposure due to:
Urban atmospheres1
Family gardens2
Interior lead paint3
Residence near smelter4
Occupational6
Secondary occupational5
Smoking7
Wine consumption8
Total
lead
consumed,
pg/day


0.5
25.1
21.0
46.6

91
48
110
880
150


1.0
54.7
4.5
60.2

28
120
17
100
1100
44
30
100
Atmospheric
lead
consumed,
ug/day


0.5
10.3
19.0
29.8

91
12

880



1.0
20.3
2.9
24.2

28
30

100
1100

27
7
Other
lead
sources,
pg/day


-
14.8
2.0
16.8


36
110




-
34.4
1.6
36.0


17




3
7
Includes lead from household (1000 pg/g) and street dust (1500 pg/g) and inhaled air
 (0.75 pg/m3).
2Assumes soil lead concentration of 2000 pg/g; all  fresh leafy and root vegetables,  sweet
 corn of Table 7-12 replaced by produce from garden.   Also assumes 25% of soil  lead  is  of
 atmospheric origin.
3Assumes household dust rises from 300 to 2000 pg/g.   Dust consumption remains  the same
 as baseline.
4Assumes household and street dust increases to 10,000 pg/g.
5Assumes household dust increases to 2400 pg/g.
6Assumes 8-hr shift at 10 pg Pb/m3 or 90% efficiency of respirators at 100 pg Pb/m3, and
 occupational dusts at 100,000 pg/m3.
70ne-and-a-half packs per day.
8Assumes unusually high consumption of one liter per day.
Source:   This report.
                                           13-10

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13.2.3.5  Lead in Other Media.   Flaking lead paint  as  well  as paint chips  and  weathered  pow-
dered paint in and  around  deteriorated housing stock in urban areas of the Northeast and  Mid-
west has long been  recognized  as a major source  of lead exposure for  young children residing
1n this housing  stock,  particularly for children with  pica.   Census data, for  example,  indi-
cate  that  there are  approximately 27 million  residential  units in the United States  built
before  1940,  many of which still  contain  lead-based paint.   Also, individuals who  are  ciga-
rette  smokers may  inhale significant amounts  of  lead  in tobacco smoke.  One study  has  indi-
cated  that  the   smoking  of 30 cigarettes daily results in  lead  intake  equivalent to  that of
inhaling lead in ambient air at a level of 1.0 ug/m3.
13.2.3.6  Cumulative Human Lead Intake From Various Sources.   Table 13-1 shows the baseline of
human  lead  exposures  in  the  United States  as described in detail in  Chapter  7.   These data
show  that atmospheric lead accounts for at least 45 percent of the baseline adult consumption
and  60  percent  of the daily consumption by a  2-yr-old  child.  These percentages are conserva-
tive  estimates  because a  part of  the lead of undetermined  origin may originate  from atmos-
pheric  lead not yet accounted for.
     From Table  13-2, it can be seen that young children have a  dietary lead intake rate that
is  5-fold greater  than for adults,  on a  body weight  basis.   To  these observations must be
added  that absorption rates for  lead are higher in  children than  in adults  by at least 3-fold.
Overall,  then,   the  rate  of lead  entry into  the blood stream  of  children,  on a body weight
basis,  is estimated  to be twice  that of  adults from  the  respiratory tract  and  six to nine
times  greater from  the GI tract.   Since children  consume more  dust  than adults, the atmos-
pheric  fraction  of the baseline exposure is  sixfold higher  for  children than for  adults, on a
body weight  basis.   These differences  generally  tend  to place young children at greater  risk,
 in  terms of  relative amounts of  atmospheric  lead  absorbed per  kg  body weight, than adults
 under any given  lead exposure  situation.
 13.3  LEAD METABOLISM:   KEY ISSUES FOR HUMAN HEALTH RISK EVALUATION
      From the detailed  discussion of those various quantifiable characteristics of lead toxi-
 cokinetics in humans and animals presented in Chapter 10, several clear issues emerge as being
 important for full evaluation of the human health risk posed by lead:

      (1)  Differences in systemic or internal lead exposure of groups within the general popu-
           lation  in terms  of  such  factors  as age/development  and  nutritional  status;  and
      (2)  The relationship  of indices of internal lead exposures to both environmental levels
           of lead and tissues levels/effects.
                                            13-11

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     Item 1 is  used  along with additional information  on  relative sensitivity to lead health
effects to  provide the basis  for  identifying segments within human populations  at  increased
risk in  terms of  exposure  criteria.   Item  2 deals with  the adequacy  of  current means  for
assessing internal  lead exposure  in  terms of  providing adequate margins of  protection  from
lead exposures which produce health effects of concern.

13.3.1  Differential  Internal Lead Exposure Within Population Groups
     Compared to  adults,  young children  take  in  more lead through the gastrointestinal  and
respiratory tracts on a unit body weight basis, absorb a greater fraction of this  lead intake,
and also  retain a greater proportion of the  absorbed  amount.   Unfortunately,  such amplifica-
tion of these basic toxicokinetic parameters in children versus adults also occurs at the  time
when:   (1) humans  are developmentally more vulnerable to the effects of toxicants  such as  lead
in terms  of metabolic  activity;  and (2) the  interactive relationships of lead with such  fac-
tors as  nutritive elements  are  such as  to  induce a negative course  toward  further exposure
risk.
     Typical of physiological  differences  in children versus adults in terms of lead exposure
implications is a more  metabolically active skeletal system  in  children.   In children, turn-
over rates of  bone elements such as calcium  and  phosphorus are greater than  in  adults,  with
correspondingly greater mobility  of bone-sequestered lead.  This  activity  is  a factor in the
observation that  the skeletal  system of children is relatively less effective as  a depository
for lead than in adults.
     Metabolic  demand  for  nutrients, particularly calcium,  iron,  phosphorus, and  the trace
elements  is  such   that  widespread deficiencies of these  nutrients  exist,  particularly among
poor children.  The interactive relationships of all of these elements with lead are such that
deficiency  states enhance  lead  absorption  and/or  retention.   In  the case  of  lead-induced
reductions  in  1,25-dihydroxyvitamin D,  furthermore, there may  exist  an increasingly adverse
interactive cycle between  lead  effects  on  1,25-dihydroxyvitamin  D and  associated  increased
absorption of lead.
     Quite  apart  from the  physiological  differences which enhance  internal  lead exposure in
children  is the unique relationship of 2- to 3-year-olds to their exposure setting by way of
normal mouthing behavior  and the extreme manifestation of this behavior, pica.  This behavior
occurs in the same age group which studies  have  consistently identified as having  a peak in
blood  lead  levels.   A number of  investigations have  addressed  the  quantification  of  this
particular  route  of lead  exposure, and  it  is by now clear  that  such exposure will dominate
other  routes  when the  child's surroundings, e.g., dust  and  soil, are significantly contami-
nated by  lead.

                                           13-12

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     Information provided in Chapter 10 also makes  it clear  that lead  traverses  the  human pla-
cental barrier, with  lead  uptake  by the fetus occurring throughout  gestation.   Such uptake  of
lead poses a  potential  threat to  the  fetus  via  an  impact on the embryological  development  of
the central nervous and  other systems.  Hence, the  only logical means of protecting the  fetus
from lead exposure is  exposure control during pregnancy.  Within the general  population,  then,
young children  and  pregnant women qualify as well-defined  groups at  high risk for  lead  expo-
sure.
     In addition, certain  emerging  information (noted in Section 13.5 and described in detail
in  the  Addendum to this document)  indicates that  increases in  blood  pressure  are  associated
with  blood  lead concentrations ranging from >30-40  ug/dl down  to possibly as low as 7 ug/dl;
this  association  appears to be particularly robust  in  white males, aged 40-59.  Occupational
exposure to lead, particularly among  lead workers, logically defines these individuals as also
being in a high-risk  category; work place contact is augmented  by those same routes and levels
of  lead exposure affecting  the rest of  the adult population.  From a biological point of view,
lead  workers  do  not differ  from the  general  adult population  with respect  to  the various
toxicokinetic  parameters  and any  differences  in  exposure  control—occupational  versus non-
occupational  populations—as  they exist are  based on factors other than  toxicokinetics.

13.3.2   Indices of  Internal  Lead  Exposure and  Their  Relationship To External  Lead Levels and
         Tissue Burdens/Effects
      Several  joints are  of importance to  consider  in the area of lead toxicokinetics:  (1)  the
temporal  characteristics of indices of lead exposure;  (2) the relationship of  these indicators
to external  lead levels;  (3) the  validity  of indicators of exposure  in  reflecting  target tis-
sue burdens;  (4)  the  interplay between these indicators and lead in body compartments; and  (5)
those various aspects of this issue that,  in particular, refer  to children.
      At this time,  blood lead is  widely held to be  the most convenient,  if  imperfect,  index of
both lead exposure and  relative  risk  for  various adverse  health effects.   In terms  of expo-
 sure, however, it is  generally accepted that blood lead is  a temporally  variable  measure which
yields an index  of relatively recent exposure because of the rather rapid  clearance of  absor-
 bed lead from  the  blood.   Such a measure,  then, is of limited  usefulness in cases  where expo-
 sure is variable or intermittent over time, as is often the case with pediatric lead exposure.
 Mineralizing  tissue  (specifically deciduous  teeth),  on the other hand, accumulate lead  over
 time in proportion to  the degree  of  lead  exposure, and analysis of this material  provides an
 assessment integrated over a greater time period.
      These two methods of assessing  internal  lead exposure have obvious shortcomings.  A blood
 lead value  will  say  little  about  any  excessive lead intake at  early periods, even  though  such
 remote  exposure  may  have  resulted  in significant  injury.   On  the other hand, whole tooth or

                                             13-13

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dentine analysis is retrospective in nature and can only be done after the  particularly vulne-
rable age  in children—under 4-5  years—has passed.   Such a measure, then, provides little
utility upon which to implement regulatory  policy or clinical  intervention.
     It may  be possible to  resolve the dilemmas  posed  by these existing  methods by iji  situ
analysis of  teeth and  bone  lead,   such  that the  intrinsic advantage of mineral tissue as a
cumulative  index  is  combined with  measurement which  is temporally  concordant  with  on-going
exposure.   Work in several  laboratories offers promise for such iji situ analysis  (See  Chapters
9 and 10).
     A second issue concerning internal indices of exposure to environmental  lead is the  rela-
tionship of  changes  in  lead  content of some  medium  with changes in blood content.  Much  of
Chapter 11 was  given over  to description of the mathematical  relationships of blood lead with
lead in some  external  medium—air,  food, water, etc.--without consideration of the  biological
underpinnings for these relationships.
     Over a  relatively  broad  range  of lead exposure  through  some medium,  the relationship  of
lead in  the external medium  to lead  in blood  is  curvilinear, such that relative change  in
blood lead per unit change  in medium level  generally becomes increasingly less as exposure in-
creases.   This  behavior  may  reflect changes in tissue lead kinetics, reduced lead absorption,
or  increased excretion.   With  respect  to  changes  in  body  lead distribution,  the  relative
amount of whole  blood  lead in plasma increases significantly with increasing whole  blood lead
content; i.e., the plasma/erythrocyte ratio increases.  Limited animal data would suggest that
changes in absorption may  be one factor in  this  phenomenon.   In any event,  modest  changes  in
blood lead  levels  with  exposure at the  higher  end of this range are in no way to be  taken  as
reflecting concomitantly modest  changes  in body or tissue lead uptake.   Evidence continues  to
accumulate which  suggests  that  an  indicator  such  as blood  lead is an imperfect measure  of
tissue lead  burdens  and of changes in such  tissue levels in relation to  changes in  external
exposure (see Figure 13-2).
     In Chapter  10,  it  was pointed out that blood lead is logarithmically  related to  chelata-
ble  lead  (the  latter being  a more useful  measure of the potentially toxic  fraction of body
lead),  such  that  a unit change in blood lead is associated with an increasingly larger  amount
of  chelatable  lead.   One  consequence  of this relationship is  that  moderately  elevated  blood
lead values  will  tend  to  mask the "margin  of  safety"  in terms of  mobile body  lead  burdens.
Such masking  is  apparent in  several studies where  chelatable lead levels  in children showing
moderate elevations  in  blood  lead  overlapped those obtained in  subjects  showing frank  plum-
bism, i.e.,  overt lead  intoxication.   In  a  multi-institutional  survey involving several hun-
dred children, it was found that a significant percentage of children with moderately  elevated
blood  lead  values had  chelatable  lead  burdens which  qualified  them for  medical  treatment.
                                           13-14

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                                                       lout
Figure 13-2. Illustration of main body compartments involved in partitioning, retention, and excretion
of absorbed lead and selected target organs for lead toxicity. Inhaled and ingested lead circulates via
blood (1) to mineralizing tissues such as teeth and bone (2), where long-term retention occurs reflective of
cumulative past exposures. Concentrations of lead in blood circulating to "soft tissue" target organs
such as brain (3), peripheral nerve, and kidney, reflect both recent external exposures and lead re-
circulated from internal reservoirs (e.g. bone). Blood lead levels used to index internal body lead
burden tend to be in equilibrium with lead concentrations in soft tissues and, below 30 /jg/dl,  also
generally appear to reflect accumulated lead stores. However, somewhat more elevated current blood
lead levels may "mask" potentially more toxic elevations of retained lead due to relatively rapid declines
in blood lead in response to decreased external exposure. Thus, provocative chelation of some children
with blood leads of 30-40 ^g/dl. for example, results in mobilization of lead from bone and other
tissues into  blood and movement of the lead (4)  into kidney (5), where it is filtered into urine and
excreted (6) at concentrations more typical of overtly lead-intoxicated children with higher blood lead
concentrations,
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     Related to the  above  is  the question of  the  source of chelatable lead.   It was  noted  in
Chapter 10  that some sizable  fraction of chelatable  lead  is  derived from bone  and that  this
compels reappraisal  of  the  notion that bone is an "inert sink" for otherwise  toxic  body  lead.
The  notion  of bone  lead  as lexicologically inert  never did  accord with what was  known  from
studies of bone physiology,  i.e., that bone is  a "living" organ.   The thrust of recent studies
of chelatable  lead,  as well as  interrelationships  of lead and bone metabolism,  supports the
view that bone lead is actually an insidious source of long-term systemic lead exposure rather
than a protective  mechanism which permits significant lead contact  in industrialized popula-
tions.
     The complex  interrelationships  of lead exposure, blood  lead, and  lead  in  body  compart-
ments  is  of particular  interest in considering  the  disposition  of  lead in  young children.
Since children take  in  more lead on a weight  basis,  and absorb and retain more of this  lead
than the  adult, one  might expect that either  tissue  and blood levels would  be  significantly
elevated or that  the child's  skeletal system  would be more efficient in  lead sequestration.
Average blood  lead  levels  in  young children  are  generally either similar to adult  males  or
somewhat higher than  for adult females.   Limited autopsy  data,  furthermore, indicate that  soft
tissue levels  in  children  are  not markedly different from adults,  whereas the skeletal system
shows  an   approximate  2-fold  increase  in  lead  concentration from  infancy   to  adolescence.
Neglected  in  this observation  is the fact that  the  skeletal  system in children grows at  an
exponential rate,  so that  skeletal  mass increases  40-fold during the  interval  in childhood
when bone lead levels increase 2-fold; this results in an actual  increase of approximately 80-
fold in total  skeletal  lead.   If the skeletal  growth factor is taken into account,  along  with
growth in  soft tissue  and  the expansion  of vascular  fluid volumes, the  question of lead  dis-
position in children is better understood.   Finally,  limited  animal  data indicate  that  blood
lead alterations with  changes  in lead exposure are poor indicators of such changes in target
tissue.  Specifically,  it appears that abrupt reduction  of lead exposure will be more rapidly
reflected  by  decreases in  blood lead than  by decreased  lead concentrations in such target
tissues as  the central  nervous system, especially  in  the  developing organism.  This  discord-
ance may  underlie the  observation  that  severe  lead neurotoxicity  in children  is  associated
with a rather broad range of blood lead values (see Section 12.4).
     The above discussion of some of the problems with the use of blood lead in assessing tar-
get  tissue  burdens or the  lexicologically active fraction of total body lead is really a sum-
mary of the toxicokinetic  problems  inherent with use of  blood lead levels in defining margins
of safety  for  avoiding internal  exposure or undue  risk  of adverse effects.   If, for  example,
blood  lead levels of  30-50 pg/dl in  "asymptomatic"  children are  associated with  chelatable
lead burdens  which  overlap those encountered  in  frank  pediatric  plumbism,  as  documented  in
several studies of  lead-exposed  children,  then  there is  no  margin of  safety at these  blood
                                           13-16

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levels for severe effects which are not at all  a matter of controversy.   Were  it both  logisti-
cal ly feasible to do  so  on a large scale and were the use  of  chelants  free of  health risk to
the subjects, serial  provocative  chelation testing would appear to be the better indicator of
exposure and risk.  Failing  this,  the only prudent alternative  is the  use of  a  large  safety
factor applied to blood  lead which would  translate to  an "acceptable"  chelatable burden.   It
is likely that this  blood lead value would  lie well  below the currently accepted upper limit
of 25 ug/dl (U.S. Centers for Disease Control,  1985),  since the safety  factor  would have to be
large enough to protect against frank plumbism as well as more  subtle health  effects seen with
non-overt  lead  intoxication.  This  rationale  from the  standpoint of  lead toxicokinetics is
also in accord with the growing data base for dose-response relationships of  lead's effects on
heme  biosynthesis,  erythropoiesis, and  the  nervous system in  humans as  detailed in  Sections
12.3 and 12.4 (see also Section 13.5, below).
     Further development and routine use of iji situ mineral tissue testing at time points con-
cordant with on-going exposure and the comparison of  such results with simultaneous blood lead
and  chelatable  lead  measurement would be  of significant value in further defining what level
of blood lead is indeed an acceptable upper limit.
 13.4   DEMOGRAPHIC CORRELATES  OF  HUMAN LEAD EXPOSURE AND  RELATIONSHIPS  BETWEEN EXTERNAL AND
       INTERNAL  LEAD  EXPOSURE  INDICES
 13.4.1  Demographic  Correlates  of  Lead  Exposure
      Studies  of ancient populations using  bone and  teeth show that  levels of internal exposure
 of lead today  are substantially  elevated over past  levels.   Studies of current populations
 living in remote areas far  from  urbanized cultures show blood  lead levels in the range of 1-5
 ug/dl.   In contrast  to the  blood lead levels found  in  remote  populations,  data from current
 U.S.  populations generally have geometric means  ranging from 10  to 20 ug/dl depending on age,
 race, sex, and  degree  of urbanization.  These higher blood lead levels in  the United States
 appear to be  associated with industrialization  and  widespread commercial  use of lead, e.g.,  in
 gasoline combustion.
      Age appears to  be one  of the most important demographic covariates of blood lead  levels.
 Blood lead levels in children up to six  years of  age are generally higher than those  in  non-
 occupational ly  exposed adults.   Children  aged  two to three  years  tend  to  have  the  highest
 levels, as shown  in  Figure  13-3.   Blood  lead levels  in  non-occupationally  exposed adults may
 increase slightly with age due to skeletal lead accumulation.
      Sex  has  a differential  impact  on blood  lead levels, depending on  age.   No  significant
 differences exist between males  and  females less than seven years of age; males above the age
 of seven  generally   have  higher  blood lead levels than  females.  Race also plays  a role, in

                                            13-17

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40
35
30
o
25
20
15
                                                .IDAHO STUDY
                                                • NEW YORK SCREENING  BLACKS
                                                • NEW YORK SCREENING • WHITES
                                                • NEW YORK SCREENING  HISPANICS
                                                 NHANES II STUDY • BLACKS
                                                 NHANES II STUDY - WHITES

                                                    \
  0123456789       10
                                      AGE, yr

  Figure 13-3. Geometric mean blood lead levels by race and age for younger children in the
  NHANES II Study (Annest et al., 1982), the Kellogg Silver Valley, Idaho Study (Yankel et
  al., 1977), and the New York Childhood Screening Studies (Billick et al., 1979).
                                      13-18

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that blacks  have  higher blood  lead levels on average  than  either whites or Hispanics.  The
reason for this is not yet  fully understood;  genetic  factors  have  yet  to  be  fully  disentangled
from differential  exposure  circumstances and  other factors.
     Blood lead levels also seem to increase  with degree of  urbanization.  Data  from NHANES  II
show that blood lead  levels in the United States, averaged  from 1976  to  1980,  increase  from a
geometric mean of 11.9 ug/dl in rural  populations to  12.8 pg/dl  in urban  populations less  than
one million,  and  increase  again  to 14.0 ug/dl  in urban populations  of one million  or more.
     Recent U.S.  blood  lead levels show a downward  trend occurring consistently  across race,
age, and  geographic  location.   This pattern commenced in the early part of  the 1970's and has
continued into  1980.   The  downward trend has occurred from a shift in the entire  distribution
and  not  through  a truncation  in  the  high  blood lead  levels.   This consistency  suggests  a
general  causative factor,  and  attempts  have been  made to  identify the  causative  element.
Reduction  in lead emitted  from the  combustion  of leaded gasoline is a prime  candidate  (See
discussion under  13.4.2).
     Distribution of  blood lead levels, examined  on a  population basis, generally have simi-
larly  skewed distributions.  That  is, blood lead  levels  from populations thought to be homoge-
nous  in terms  of demographic  and  lead exposure  characteristics  generally  follow an approxi-
mately lognormal  distribution.  Geometric  standard  deviations  (an estimation of  dispersion)
for  observed  distributions from  four  different  studies  discussed  in  Chapter 11 (including
analytic  error)  are  about 1.4  for children and  possibly  somewhat  smaller  for  adults.  This
allows an estimation  of the upper  tail  of the blood  lead distribution for the U.S.  population,
which  would  be the population  segment expected to be at greater risk.

13.4.2  Relationships Between  External  and  Internal  Lead Exposure Indices
      There  is  no question that, across a broad  spectrum  of external air  lead concentrations
 ranging upward to beyond   10-20 H9/m3« the relationship  between  air  lead exposures  and  in-
 creases in  blood  lead levels is nonlinear.   However, because  one  main purpose  of  this document
 is to  examine relationships of  lead in air and  lead  in  blood under ambient  conditions,  the
 results of  studies most appropriate for this purpose were emphasized  in  Chapter 11.   A summary
 of the most appropriate studies  appears in Table 13-4.  At air lead  exposures of 3.2 pg/m3 or
 less,  there  is  no statistically  significant  difference between curvilinear and  linear  blood
 lead  inhalation  relationships.  Also,  for  air lead exposures of 10 jjg/m3 or more, either non-
 linear or linear relationships can be fitted.  Thus,  a reasonably consistent picture emerges
 in which the blood lead-air lead relationship by direct inhalation appears to be approximately
 linear  in  the range  of normal ambient  exposures  (0.1-2.0 MO/m3) as discussed  in Chapter 7.
 Differences among individuals  in  a given study,  and among several  studies are large, so that

                                            13-19

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                      TABLE 13-4.   SUMMARY OF BLOOD INHALATION  SLOPES  (p)
Population Study
Children Angle and
Mclntire (1979),
Omaha, NE
Roels et al.
(1980),
Belgium
Yankel et al.
(1977); Walter
et al. (1980),
Idaho
Adult Males Azar et al.
(1975), five
groups
Griffin et al.
(1975), NY
prisoners
Gross
(1979)
Rabinowitz et
al. (1973,1976,
1977)
Study
Type N
Population 1074


Population 148


Population 879



Population 149


Experiment 43


Experiment 6

Experiment 5


Slope (B),
ug/dl per ug/m3
1.92


2.46


1.52



1.32


1.75


1.25

2.14


Model sensitivity
of slope
(1.40 - 4.40)b


(1.55 - 2.46)b


(1.07 - 1.52)b



(1.08 - 2.39)c


(1.52 - 3.38)e


(1.25 - 1.55)c

(2.14 - 3.51)f


,c,d


,c


,c,d



,d










 Selected from among the most plausible statistically equivalent models.   For nonlinear
 models, slope at 1.0 ug/m3.
 Sensitive to choice of other correlated predictors such as dust and soil  lead.
cSensitive to linear vs. nonlinear at low air lead.
 Sensitive to age as a covariate.
Sensitive to baseline changes in controls.
 Sensitive to assumed air lead exposure.
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pooled estimates of  the  blood  lead inhalation slope depend upon the the weight given to vari-
ous studies.  Several  studies  were selected for analysis,  based upon factors described earli-
er.   EPA  analyses  of experimental and clinical  studies  (Griffin et al., 1975;  Rabinovritz  et
al.,  1973,  1976, 1977;  Kehoe 1961a,b,c;  Gross 1981; Hammond  et al.,  1981)  suggest that blood
blood  lead  in adults increases by approximately  1.64  ±  0.22 ug/dl from direct  inhalation  of
each  additional  ug/m3 of  air  lead.   EPA  anaylsis of Azar's  population study  (Azar et al.,
1975) yields a slope of 1.32 ± 0.38 for adult males.  EPA analyses of other  population studies
(Yankel et  al.,  1977; Roels et al., 1980;  Angle and Mclntire, 1979) suggest that, for child-
ren,  the  blood lead  increase  is  approximately  1.92 (a median estimate) ug/dl  per each ug/m3
increment of air lead.
      These  slope estimates are based on the assumption that an equilibrium level of blood lead
is  achieved within a  few months after exposure begins.   This is only approximately true, since
lead  stored in the skeleton may  return  to blood after some years.  Chamberlain et al. (1978)
suggest  that long-term inhalation slopes  should be about 30  percent  larger than these esti-
mates.   Inhalation  slopes  quoted here are associated with a half-life  of blood  lead  in adults
of  about 30 days.  O'Flaherty  et  al. (1982) suggest that the blood  lead half-life may increase
slightly  with  duration  of  exposure,  but this  has not been  confirmed (Kang  et  al.,  1983).
      One  possible  approach would be to  regard  all inhalation slope studies  as  equally infor-
mative and  to calculate an  average slope  using  reciprocal squared  standard  error estimates as
weights.  This approach has been  rejected for  two reasons.   First,  the standard error estima-
tes characterize only the  internal precision  of  an estimated  slope,  not its  representativeness
(i.e., bias) or predictive  validity.  Secondly,  experimental  and clinical studies obtain more
information from a single  individual than do population studies.  Thus, it may not  be appro-
priate to combine the two  types  of studies.
      While  estimates of the inhalation  slope for children are  only available from population
studies,  the importance of  dust  ingestion as a  non-inhalation  pathway for  children  is  estab-
 lished by  many  studies.   Slope  estimates have been derived  for air lead inhalation based on
several  such studies  (e.g., Angle and Mclntire 1979;  Roels  et al., 1980; Yankel et  al.,  1977)
 from  which  the  air  inhalation  and  dust  ingestion  contributions  can both  be  estimated.
Brunekreef   (1984)   reviewed  these  and  other  studies  and  found  wide variations  in  slope
 estimates that include aggregate impacts of direct inhalation and indirect  dust contributions.
 Such aggregate analyses from some of the better conducted studies yield slope estimates in  the
 general range of 4-6 ug/dl blood lead per ug/m3 air lead increase.   Also, results from another
 recent analysis (Angle  et al.,  1984)  suggest that indirect soil/dust contributions contribute
 blood  lead increases of 4-5 ug/dl in addition to the direct  inhalation contribution  of 1.92
 ug/dl blood lead per ug/m3 air lead.

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     While direct  inhalation  of  air lead is stressed, this is not the only air lead contribu-
tion  that  needs  to be considered.  Smelter  studies  allow partial assessment of the  air  lead
contributions to soil,  dust,  and finger lead.   Conceptual models allow preliminary estimation
of the propagation  of lead through the total  food  chain as shown in Chapter 7;  useful  mathe-
matical models to  quantify this  propagation through the food chain need to be developed.   The
direct inhalation  relationship does  provide useful   information  on changes  in blood  lead in
response to  changes  in  air lead on  a time scale  of several months.   However, the  indirect
pathways through  dust and   soil  and  through  the food  chain may delay the  total  blood  lead
response to  changes  in  air lead, perhaps by one or more years.   The Italian ILE  study facili-
tates partial assessment of this  delayed response from leaded gasoline as a source.
     Dietary absorption  of lead  varies greatly from  one  person  to another and depends on the
physical  and chemical  form of the carrier,  on  nutritional  status, and on whether  lead is in-
gested with food or between meals.  These distinctions are particularly important for consump-
tion  by children  of leaded paint, dust, and soil.  Typical values of 10 percent absorption of
ingested lead into blood have been assumed for adults and 25-50 percent for children.
      It is  difficult to determine  accurate  relationships between blood lead  levels  and  lead
levels in  food or  water.  While  dietary  intake  must  be estimated by duplicate diets or fecal
lead  determinations,  water lead  levels can be  determined with  some  accuracy.  However,  the
varying amounts of water consumed by different individuals add to the uncertainty of the esti-
mated relationships.
     Quantitative analyses relating blood lead levels and dietary lead exposures  have been re-
ported.  While  studies  on  infants  provide  estimates  that are  in close  agreement,  only one
individual  study is  available for adults (Sherlock et al. 1982); another estimate  from a  num-
ber of pooled  studies is also available.   These two estimates are in good agreement.   Most of
the subjects in  the Sherlock et  al. (1982) and United Kingdom Central Directorate  on Environ-
mental Pollution  (1982) studies  received  quite  high  dietary lead  levels  (>300  ug/day).   The
fitted cube  root equations give  high slopes at lower dietary lead levels.   On the  other hand,
the linear slope of the United Kingdom Central  Directorate on Environmental Pollution (1982)
study  is  probably  an underestimate  of the slope at lower  dietary  lead  levels.   For  these
reasons,  the Ryu et al.  (1983) study appears to be the most reliable, although it only applies
to infants.   Estimates  for  adults  can be  obtained  from the experimental  studies,  but would
most  appropriately  apply at high exposure levels (e.g.,  >300 ug/day).   in such  studies,  most
of the dietary  lead intake supplements were so  high  that many of the subjects had blood  lead
concentrations much  in  excess of 30  ug/dl  for a considerable  part  of the experiment.   The
blood  lead levels  thus  may not have completely reflected lead exposure, due to the previously
noted  nonlinearity  of blood lead response  at  high  exposures.  The  slope  estimates  for adult
dietary intake are  about 0.02 ug/dl increase in  blood lead per ug lead/day total  intake, but
                                           13-22

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consideration of blood lead kinetics may increase this  value to about 0.04.   Such values  are  a
bit lower than those estimated from the population studies extrapolated to typical  dietary in-
takes:  that is, about 0.05 ug/dl  per ug/day.   The Ryu  et al.  (1983)  value for infants is much
larger, being about 0.16 ug/dl per ug/day.
     The relation  between  blood  lead and water  lead is  not clearly  defined and  is  often de-
scribed  as  nonlinear.   Water lead  intake varies  greatly from one person to  another.   It has
been  assumed  that  children can absorb  25-50 percent of  lead in water.  Some authors chose to
fit cube root models to their data, although polynomial and logarithmic models were also used.
Unfortunately,  the  form of the model greatly  influences  the estimated contributions to blood
lead  levels from relatively low water lead concentrations.
      Although  there  is close  agreement in  the  quantitative analyses  of  the  relationship
between  blood  lead level  and dietary lead,  there is a larger degree of variability in results
of  the  various water lead studies.  Over a wide range of water lead concentrations, the rela-
tionship  is curvilinear,  but its  exact  form  has yet to  be  determined.   At typical ambient
water levels  for  U.S.  populations,  the  relationship  appears  linear.   The  only  study that
determines  the relationship based  on lower water lead values  (<100 ug/1) is the Pocock et al.
(1983)  study.   The data from this  study, as  well as  the  authors themselves,  suggest that the
relationship  is linear in this lower  range of water  lead  levels.  Furthermore, the estimated
contributions  to blood  lead  levels in this  study  are  quite consistent with the polynomial
models  from other studies.   For  these  reasons,  the  Pocock  et  al. (1983)  slope of 0.06 is con-
sidered  to  represent  the  best  estimate.   The  possibility  still  exists,  however,  that the
higher  estimates of  the  other studies may be  correct  in  certain  situations,  especially at
higher water  lead  levels  (>100 ug/1).
      Studies  relating soil lead  to blood lead levels  are  difficult  to compare.  The relation-
ship  obviously depends  on  depth of soil lead,  sampling method, cleanliness  of  the home, age of
the children, mouthing activities  of  the children,  and possibly many other factors.  Various
soil  sampling methods  and  sampling depths  have been  used  over  time,  and as such they may not
be directly comparable and may  produce a dilution  effect of the  major lead concentration con-
tribution   from  dust,  which  is  located primarily in  the top  2  cm  of the  soil.  Increases  in
soil  dust  lead significantly increase  blood lead in children.   From  several studies (Yankel  et
al.,  1977; Angle  and  Mclntire,  1979)  EPA estimates an increase  of  0.6-6.8  ug/dl  in blood lead
 for each increase  of  1000 ug/g  in soil lead  concentration.   The values from the Stark et al.
 (1982) study  of about  2  ug/dl  per 1000 ug/g  may represent a reasonable median estimate.  The
 relationship of housedust lead to blood lead  is difficult to obtain.    Household dust also in-
 creases blood lead, as children from the cleanest homes in the Silver Valley/Kellogg Study had
 6  ug/dl  less  lead  in  blood, on average, than  those  from the households  with  the most dust.
                                            13-23

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     A number of  specific  environmental  sources of airborne  lead  have  been  evaluated  for  po-
tential direct influence on blood lead levels.   Combustion of leaded gasoline appears to  be an
extremely important contributor  to  airborne lead in the United States,  as  indicated by strong
associations between reductions  in  nationwide  gasoline lead usage  and average U.S. blood lead
levels determined  by  a major population survey  on  a  nationwide level.   Studies of data from
blood  lead  screening programs  in specific U.S.  metropolitan areas  also suggest that the  down-
ward trend  in blood  lead levels noted earlier is due  to reductions in air  lead levels, mainly
attributable to reductions of lead in gasoline.
     In addition,  other  studies  used isotope ratios of  lead  to estimate the relative  propor-
tion of lead  in  the  blood coming from airborne  lead  or, more specifically,  from leaded  gaso-
line usuage.  For example, from the Isotopic Lead Experiment (ILE)  data of  Facchetti and  Geiss
(1982) and  Facchetti   (1985),  as shown in  Table  13-5,  the direct  inhalation of air lead  may
account for 60 percent of the total  adult  blood lead  uptake from leaded gasoline in  a  large
urban  center, but  inhalation is a much less important pathway in suburban  parts of the region
(19 percent of the total gasoline lead contribution)  and  in the rural  parts of the region (9
percent of  the  total  gasoline lead  contribution).   EPA analyses of the  preliminary  results
from the  ILE  study separated the inhalation and  non-inhalation contributions of leaded  gaso-
line to  blood lead  into the  following  three  parts:    (1)  an increase of  about 1.7 ug/dl  in
blood  lead per (jg/m3 of air lead, attributable to direct inhalation of the  combustion products
of leaded gasoline;  (2)  a sex difference of about  2  ug/dl attributable to  lower  exposure of
women  to  indirect  (non-inhalation)  pathways for gasoline lead; and (3) a non-inhalation  back-
ground attributable  to indirect gasoline lead  pathways,  such as  ingestion  of  dust and  food,
increasing  from about  2  M9/dl  in Turin to  3 ug/dl  in  remote rural areas.   The non-inhalation
background represents only two to three years of environmental accumulation at the new  experi-
mental  lead isotope  ratio.   It is not clear how to numerically extrapolate these estimates to
subpopulations in  the  United States; however,  it is  evident that even  in rural  and  suburban
parts  of  a metropolitan  area,  the  indirect (non-inhalation) pathways  for exposure to leaded
gasoline make a  significant contribution to blood  lead.  This can  be seen  in  Table 13-5.   It
should also be noted that the blood lead isotope ratio responded fairly rapidly when  the  gaso-
line lead  isotope  ratio  returned to  its pre-experimental value, but it is  not yet possible to
estimate  the  long-term  change  in  blood  lead attributable to  persistent exposures to  accumu-
lated  environmental lead.
     The  strongest kind  of scientific evidence  about  causal  relationships  is based  on an  ex-
periment  in which  all  possible extraneous  factors  are controlled.  The evidence derived from
the  Isotopic  Lead Experiment  comes  very close.   The experimental  intervention consisted of
                                           13-24

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            TABLE 13-5.  ESTIMATED CONTRIBUTION OF LEADED GASOLINE TO BLOOD LEAD
                          BY INHALATION AND NON-INHALATION PATHWAYS


Location
Turin
<25 km
>25 km

Air lead
fraction
from
gaso-
line3
0.873
0.587
0.587

Mean
air
lead b
cone. ,
ug/m3
2.0
0.56
0.30

Blood Pb
fraction
from
gaso-
linec
0.214
0.114
0.101

Mean
blood
lead
cone. ,
MQ/dl
21.77
25.06
31.78
Blood
Pb
from
gaso-
line,
Mg/dl
4.66
2.86
3.21
Pb
from
gaso-
line -
in air,
Mg/dl
2.79
0.53
0.28
Non-
inhaled
Pb from
gaso-
line,
ug/dl
1.80
2.33
2.93

Estimated
fraction
gas-lead
inhala-
tion"
0.60
0.19
0.09
 Fraction of air lead in Phase  2 attributable  to lead  in  gasoline.
 Mean air lead in Phase 2,  ug/m3.
cMean fraction of blood lead in Phase 2 attributable to lead in  gasoline.
 Mean blood lead concentration  in Phase 2,  ug/dl.
eEstimated blood lead from gasoline = (c) x (d).
 Estimated blood lead from gas  inhalation = B  x (a) x (b), B = 1.6.
^Estimated blood lead from gas, non-inhalation = (f)-(e).
 Fraction of blood lead uptake from gasoline attributable to direct inhalation = (f)/(e).
Data: Facchetti and Geiss (1982); Facchetti (1985).

replacing the normal 206Pb/207Pb isotope ratio by a very different ratio.   There is no plausi-
ble  mechanism  by  which other concurrent  lead exposure  variables (food, water,  beverages,
paint,  industrial  emissions)  could  have also  changed their isotope  ratios.   Hence  the  very
large  changes  in  isotope  ratios  in blood were  responding to  the change in  gasoline.   Our
analyses  (Chapter  11)  show that consideration  of  inhalation  of community air  lead alone pro-
bably  substantially  underestimates the total  effect  of  gasoline lead, at least in the 35 sub-
jects whose  blood  leads were tracked  in  the ILE Preliminary Study.  Spengler et al. (1984), as
discussed  in Section  11.3,  also suggest  that  part  of  the extra  exposure could  possibly be
attributed  to exposure to  higher-than-ambient  air lead  concentrations inside motor vehicles,
e.g.,  on the trip to  work; however,  no data are  presently available  to  confirm this  hypothe-
sis.
      Primary lead  smelters, secondary lead smelters,  and battery plants emit  lead  directly  in-
 to the  air  and ultimately  increase soil  and dust lead concentrations  in  their  vicinity.
 Adults,  and  especially children,  have been  shown  to exhibit elevated blood  lead  levels  when
 living close  to these sources.   Blood lead  levels  in  these residents  have been  shown  to be
                                            13-25

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related to  air lead, as  well  as  to  soil or  dust  lead exposures.   In addition,  individuals
(especially  children)  living  in  housing  units  with  deteriorating  or weathering  lead-based
paint may also be  exposed via  lead accumulated in dust or  soils within or  around their dwell-
ings.

13.4.3   Proportional Contributions of Lead in  Various  Media  to Blood Lead
         in Human Populations
     The various mathematical  descriptions  of  the relationship of blood lead  to  lead  in  indi-
vidual media—air,  food,  water,  dust, soil—were discussed  in some  detail in Chapter 11  and
concisely in the preceding section (13.4.2) of  this  chapter.   Using values for lead intake/
content of  these media  which appear to represent the  current exposure  picture  for  human  popu-
lations in  the United  States,  these relationships are further  employed  in  this  section  to
estimate proportional inputs to total  blood lead  levels in  U.S. children.   Such an  exercise is
of help in  providing an overall  perspective on  which  routes of exposure are  of  most  signifi-
cance  in  terms of  contributions to blood  lead levels  seen especially  in  urban children,  the
population  group  in the  United  States at greatest risk for lead  exposure and its toxic  ef-
fects.
     Table  13-6 tabulates  the  relative direct contributions  of air  lead to blood lead at dif-
ferent air  lead  levels  for calculated typical  background levels of  lead from  food, water,  and
dust for children in the United States.   Also listed are the  direct  and indirect  contributions
of air lead to blood lead at  varying  air lead levels for children, given calculated typical
background  levels  of blood lead.   Calculations and  assumptions  used in deriving  the estimates
shown  in  Table 13-6  are summarized in footnotes  to  that table.  The diet contributions  listed
in  the table,  for  example,  are  based  on the  following:    (1)  estimated   average background
levels of  lead  (from  non-air and  air   sources)  in   food  ingested per day  by children,  as
delineated  in  Table  7-19;  and  (2) the value of  0.16  ug/dl  of blood increase  per  ug/day food
lead  intake found  by Ryu et al.  (1983)  for infants.   Similarly,  values for  other parameters
used in Table 13-6 are obtained from work discussed in Chapters  7  and 11.
     It is  of  interest  to compare (1) estimated blood lead  values  predicted  in  Table 13-6 to
occur  at  particular air  lead  concentrations with  (2) actual blood lead  levels observed  for
children  living  in the  United  States in areas with comparable ambient air  concentrations.   As
an  example, NHANES  II  survey  results for  children  living  in rural  areas   and urban  areas of
more than  one  million population  or less  than one  million were  presented  in  Table 11-5.  For
children  (aged 0.5-5 yr)  living in urban  areas  of  >1 million,  the  mean blood lead value  was
16.8 ug/dl,  a  value  representative of average blood lead levels  nationwide  for preschool  chil-
dren  living in large  urban areas during the  NHANES survey period  (1976  to  February,  1980).
                                           13-26

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Ambient air lead  concentrations  (quarterly  averages)  during the same time period  (1976-1979)
for  a  geographically diverse sample  of large  urban  areas in  the  United States  (population
>1 million) 9^ available  from Table  7-3.   The air lead levels  during 1976-1979  averaged  1.06
pg/m3  for  all  cities listed  in  Table 7-3 and 1.12 ug/m3  for eight cities in the table  that
were included  in  the NHANES II  study (i.e., Boston, New York, Philadelphia,  Detroit,  Chicago,
Houston,  Los  Angeles, and  Washington,  DC).   The  Table 13-6  blood  lead  values of  12.6-14.6
ug/dl  estimated   for  air  lead  levels of 1.0-1.25 ug/m3 approximate the  observed NHANES  II
average  of 16.8  ug/dl   for children in  large urban  areas with average  air lead levels  of
1.06-1.12  ug/m3.   The NHANES  II  blood lead values for preschool children would be  expected to
be  somewhat  higher than  the estimates in Table 13-6  because  the latter were derived from FDA
data for  1981-1983,  which were  lower than  the FDA values for the  1976-1980  NHANES  II  period
(see Chapter 7).   FDA data for  food, water, and beverages for the 1976-1980 period are not in
a  form exactly comparable to the 1981-1983 data  used in calculating background contributions
1n  Table 13-6, but  do  suggest  that  lead levels  in those media declined  by about 20 percent
from the  1976-1980 period to 1981-1983.  If background contributions  in Table 13-6 were cor-
rected (i.e.,  increased  by 20 percent) to be comparable  to  the   1976-1980  period,  then the
blood  lead levels of children exposed  to 1.25 ug/m3  air lead would increase to 15.5 ug/dl, a
value  even closer  to the  mean  of 16.8 ug/dl  found  for NHANES  II children  living  in urban
environments (>1  million)  during 1976-1980.
 13.5  BIOLOGICAL EFFECTS OF LEAD RELEVANT  TO  THE  GENERAL  HUMAN  POPULATION
 13.5.1  Introduction
      It is  clear from  the  wealth of available  literature  reviewed  in Chapter 12 that there
 exists a  continuum  of biological effects associated with  lead across  a broad range of expo-
 sure.   At rather low levels of lead exposure, biochemical changes,  e.g., disruption of certain
 enzymatic activities  involved in heme biosynthesis and  erythropoietic pyrimidine metabolism,
 are detectable.  Heme biosynthesis  is a  generalized  process  in mammalian species,  including
 man,  with  importance  for normal  physiological  functioning of  virtually  all organ  systems.
 With  increasing  lead  exposure,  there are sequentially more intense  effects  on heme  synthesis
 as well as  a broadening of effects  to  additional  biochemical  and physiological  mechanisms in
 various tissues.  In addition to heme biosynthesis impairment at relatively low levels of  lead
 exposure, disruption of normal functioning of the erythropoietic and nervous systems are among
 the earliest effects observed  as  a function of increasing lead exposure.   With increasingly
 Intense exposure, more  severe disruption of the erythropoietic and  nervous systems occur and
 additional  organ systems  are  affected,  resulting,  for example,  in manifestation  of renal

                                            13-27

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         TABLE 13-6.   CONTRIBUTIONS FROM VARIOUS MEDIA TO BLOOD LEAD  LEVELS  (ug/dl) OF
   U.S.  CHILDREN (AGE = 2 YEARS):   BACKGROUND LEVELS AND INCREMENTAL  CONTRIBUTIONS FROM AIR


                                                      Air lead, ug/m3
Source
Background-non air
Food, Water and
Beverages
Subtotal
0
2.37
0.30
O7
0.25
2.37
0.30
2.67
0.50
2.37
0.30
2767
0.75
2.37
0.30
2.67
1.00
2.37
0.30
2.67
1.25
2.37
0.30
2767
1.50
2.37
0.30
2T67
Background-air
Food, Water and
  Beverages0            1.65      1.65      1.65       1.65       1.65       1.65        1.65
deposited
Inhaled air
Total
from air)
e
0.00
0.00
4.32
1.57
0.50
6.39
3.09
1.00
8.41
4.
1.
10.
70
50
52
6.
2.
12.
27
00
59
7.
2.
14.
84
50
66
9.40
3.00
16.72
aFrom Table 7-19, (25.1 - 10.3) ug/day x (0.16 from Ryu et al.,  1983)  = 2.37 ug/dl.
 From Chapter 7, 1/10 dust not atmospheric.   Using Angle et al.  (1984) low area (Area S)
 for soil and house dust and their regression equation, we have:   (1/10) x (97 ug/g  x
 0.00681 + 324 ug/g x 0.00718) = 0.30 ug/dl.   Alternatively, the consumption from non air
 would be (1/10) x (97 ug/g soil dust + 324 ug/g house dust) x 0.05 grains ingested of
 each = 2.1 ug ingested.  Using Ryu et al.  (1983), 2.1 x 0.16 = 0.34 ug/dl added to  blood.

cAs in (a) above, but using 10.3 instead of (25.1 - 10.3) yields 1.67 ug/dl.  Values are
 derived for component of background Pb in food from past deposition from air onto soil and
 into other media leading into human food chain (not expected to change much except  over
 long-term).
 The regression equations of Angle et al. (1984) are used, as well as levels of soil dust
 and house dust in the low area (S) and high area (C) of that study.  For example, the
 increase at 1.0 ug/m3 in air would result in increases in soil  as follows:

                           Oias "- 0!29   x   (519-97)   = 526 ug/g
 Similarly the increase in house dust would be:
                                             (625 - 324)  = 374 ug/g
 The effect on blood lead would be (526 x 0.00681) + (374 x 0.00718) = 6.27 ug/dl .
eUsing the 2.0 slope from Angle et al. (1984), i.e., 1.93 rounded up.
                                           13-28

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effects, disruption of reproductive  functions,  and impairment  of immunological  functions.  At
sufficiently high levels of  exposure,  the damage to the  nervous  system and  other  effects  can
be severe  enough to  result  in death  or,  in some  cases  of non-fatal  lead  poisoning,  long-
lasting sequelae such as  permanent mental  retardation.
     As discussed in Chapter 12 of this document, numerous new  studies,  reviews, and critiques
concerning lead-related health  effects  have  been published since the issuance  of  the earlier
EPA Lead Criteria Document in 1977.  Of particular importance for present criteria  development
purposes are those  new findings,  taken together with  information  available  at the writing of
the  1977  Lead  Criteria  Document,  which  have  bearing on  the establishment of quantitative
dose-effect or  dose-response  relationships which can be  potentially viewed  as  adverse health
effects  likely  to  occur  among the general population  at  or near existing ambient  air concen-
trations  of lead  in  the United  States.   Key  information  regarding  observed  health effects
and their  implications are discussed below for adults and children.
     For the  latter group,  children, emphasis is placed on the discussion of (1) heme biosyn-
thesis  effects,  (2) certain other biochemical  and  hematological  effects,  and (3)  the disrup-
tion of nervous system functions.  All of these appear to be among those effects of most con-
cern for potential  occurrence in  association with  exposure to existing U.S. ambient air lead
levels  for the population group  at greatest risk for  lead-induced health effects (i.e., chil-
dren £6 years  old).   Emphasis is  also placed  on  the delineation of  internal lead exposure
levels,  as defined mainly by blood  lead  (PbB)  levels  likely associated with the occurrence of
such effects.   Also discussed are characteristics  of  the subject effects that  are of crucial
importance with regard to the  determination  of which  might reasonably  be viewed as  constitu-
ting "adverse  health  effects"  in  affected  human populations.
     Over  the  years,  there have  been  superimposed  on  the continuum of  lead-induced biological
effects various judgments  as to  which specific effects  observed in  man constitute "adverse
health  effects."  Such judgments  involve  not only  medical  consensus regarding  the  health  sig-
nificance  of particular effects  and their clinical management, but also incorporate societal
value  judgments. Such societal value  judgments often  vary  depending upon the specific  overall
contexts in which  they are  applied;  e.g., in  judging permissible exposure  levels  for  occupa-
tional  versus  general  population exposures  to lead.   For some lead exposure  effects, e.g.,
severe  nervous  system damage  resulting in death or serious medical sequelae consequent to in-
tense   lead  exposure,  there  exists  little or  no  disagreement  as to  these  being  significant
 "adverse health effects."   For many other effects detectable  at  sequentially  lower levels  of
 lead exposure, however,  the demarcation lines as to which effects represent  adverse health ef-
 fects  and the  lead exposure levels at which they  are accepted as occurring are neither sharp
                                            13-29

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nor fixed, having changed markedly during the past several  decades.   That is,  from  an  histori-
cal perspective,  levels  of lead  exposure  deemed  to be acceptable for either  occupationally-
exposed persons or the general  population have been steadily revised downward as more sophis-
ticated biomedical techniques have  revealed  formerly unrecognized biological  effects  and  con-
cern has  increased in regard  to the medical  and  social  significance of such effects.   As  a
concrete example, pediatric blood lead  concentrations deemed to  be  associated with unaccept-
able risk  of lead toxicity  have been  repeatedly  revised  downward by the U.S. Public  Health
Service (see CDC, 1985).
     It is difficult  to  provide a definitive statement of  all criteria by which  specific  bio-
logical effects associated with any given agent can be judged to be "adverse  health effects."
Nevertheless, several criteria  are  currently well-accepted as helping to define  which effects
should be  viewed  as  "adverse."   These include the following:  (1) impaired normal  functioning
of a specific tissue  or  organ  system itself;  (2)  reduced  reserve capacity of that tissue  or
organ  system in dealing  with  stress due  to other  causative agents; (3)  the reversibility/
irreversibility of the particular effect(s);  (4) the relative frequency of a given  effect; (5)
presence of  the  effect  in a vulnerable  segment of  the population; and  (6) the  cumulative  or
aggregate impact of various effects on individual  organ systems on the overall  functioning and
well-being of the individual.
     Examples of  possible uses  of  such  criteria  in evaluating lead effects can be cited for
illustrative purposes.   For example,  impairment of heme synthesis intensifies with increasing
lead exposure until  hemoprotein synthesis is  inhibited in  many  organ systems, leading to re-
ductions  in  such functions as  oxygen transport, cellular  energetics,  neurotransmitter func-
tions, detoxification of xenobiotic agents,  and biosynthesis  of  important substances such as
1,25-dihydroxyvitamin D.   In Figure 13-4, the far-ranging impact of lead on the body heme pool
and associated disruption of many physiological processes is depicted, based on data discussed
in Sections 12.2 and 12.3.  Furthermore, inspection of Figure 13-4 reveals effects  that can be
viewed as  intrinsically  adverse as well as  those  that reduce the body's ability to cope with
other forms of toxic stress, e.g.,  reduced hepatic detoxification of many types of  xenobiotics
and, possibly,  impairment of the  immune  system.   The liver effect can also be  cited as  an
example of reduced  reserve capacity pertinent to consideration of the effects of lead, as the
reduced capacity  of  the  liver  to  detoxify  certain drugs  or other  xenobiotic agents results
from lead effects on hepatic detoxification enzyme systems.
     In regard to the issue of  reversibility/irreversibility  of lead effects, there are really
two dimensions  to the issue that need to be considered, i.e.: (1) biological reversibility or
irreversibility characteristic  of the particular effect in  a  given organism; and (2) the gene-
rally  less-recognized concept  of exposure reversibility  or irreversibility.   Severe central

                                           13-30

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REDUCTION OF
HCMt BODY POOL



RYTHROPOIETIC REDUCED AIIEMIA - REDUCED
SYNTHESIS TO ALL TISSUES

EXACERBATION OF
OTHER STRESS AGENTS

/
EFFECTS ON NEURONS
AXONS. AND
SCHWANN CELLS
/ *
NEURAL REDUCED HEMOFROTElNS IMPAIRED j
EFIICTI "" IM..CYTOCHROMESI ~*~ IHIULAR h-»-
ENERGETICS \
\
DISTURBED IMUNO
RECULATORVRDLE
41 OF CALCIUM 4
1
RENAL ENDOCRINE^ R[DUCED I.!S (OKI, - / ^ DISTUHIED CALCIUM / ^
EFFICTI VITAMIN 0 \ METABOLISM \~
» \
IMPAIRED MVELINATION
AND NERVE CONDUCTION

IMPAIRED DEVELOPMENT
OF NERVOUS SYSTEM


TISSUE HONEOSTASIS

IMPAIRED CALCIUM
ROLE AS SECOND
MESSENGER
\
* DISTURBED ROLE IN *
TUMORICENESIS
CONTROL
X
1 IMPAIRED /
J DETOXIFICATION /
^| OF IENOBIOTICS \
/ \
MIPAT.C __j ""UCEOHEMEFOR ]/
EFFECTS H HEMERECULAIEU I
\ TRANSFORMATIONS |\
"~" ~~~ \ . 	 /
VI IMPAIRED METABOLISM /
OFENDOCiNOUS V
AGONISTS [\
IMPAIRED CALCIUM
ROLE IN CYCLIC
NUCLEOTIDE METABOLISM

IMPAIRED DETOXIFICATION
rOF ENVIRONMENTAL
TOXINS
CARDIOVASCULAR
OTHER HVPOXIC EFFECTS


TOOTH DEVELOPMENT


]

IMPAIRED
DETOXIFICATION
OF DRUGS


I ALTERED METABC: ISM
1 OF TRYPTOPHAN
ELEVATED BRAIN
-•M LEVELS OF TRYPTOPHAN,
[ SEROTONIN. ANOHIAA
t
IMPAIRED DISTURBED INOOLEAMINE
J HVDROXYLATION NEUROTRANSMITTER
1 OF COKIISOl | FUNCTION
Figure 13-4. Multi-organ impact of reductions of heme body pool by lead. Impairment of home
synthesis by lead (see Section 12.3) results in disruption of a wide variety of important physio-
logical processes in many organs and tissues. Particularly well documented are erythropoietic,
neural, renal-endocrine, and hepatic effects indicated above by solid arrows (	»-). Plausible
further consequences of heme synthesis interference by  lead which remain to be more conclu-
sively established are indicated by dashed arrows (	•*»).
                                      13-31

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nervous system damage  resulting  from Intense,  high-level lead exposure  Is  generally accepted
as an  irreversible effect  of  lead exposure;  the reversibility/irreversibility  of certain more
difficult-to-detect  neurological  effects occurring  at  lower  lead  exposure levels, however,
remains a matter  of  some controversy.   The concept of  exposure  reversibility/irreversibility
can be  illustrated by  the  case of urban children of  low socioecomomic  status showing disturb-
ances  in  heme biosynthesis and  erythropoiesis.   Biologically,  these  various  effects may be
considered reversible;  the extent to which actual reversibility occurs,  however,  is  determined
by the feasibility of removing these subjects from their particular  lead exposure setting.  If
such  removal  from exposure is  unlikely or  does  not  occur,  then such  effects will  logically
persist and, defacto, constitute essentially  irreversible effects.
     The  issues  of frequency of  effects and  vulnerable segments of  the  population in whom
these  effects  occur  are intimately  related.    As  detailed later in  Section 13.7, young chil-
dren—particularly inner-city  children—constitute  a  high risk  group  because  they do show  a
high frequency of certain health effects, as  summarized below.

13.5.2  Dose-Effect Relationships for Lead-Induced Health Effects
13.5.2.1  Human Adults.  The  lowest  observed effect  levels  (in terms  of blood  lead  concentra-
tions) thus far credibly associated with particular health effects of  concern for human adults
in relation to specific organ systems or generalized physiological  processes,  e.g., heme  syn-
thesis, are summarized in Table 13-7.  That table should be  viewed as  representing  lowest  blood
lead  levels thus  far  credibly associated with unacceptable risk for  a given effect occurring
among  at  least some adults.   As such,  many other  individuals may  not  experience  the stated
effect until distinctly higher blood lead levels are  reached,  due to wide ranges  of  individual
biological susceptibility,  variations in nutritional  status,  and other factors.
     The most  serious  effects  associated with  markedly  elevated  blood  lead levels  are severe
neurotoxic  effects  that include  irreversible  brain  damage,  as  indexed by the occurrence of
acute  or  chronic encephalopathic  symptoms observed  in both humans and experimental animals.
For most  human adults,  such  damage typically  does  not occur until blood  lead  levels exceed
100-120 ug/dl.  Often  associated  with  encephalopathic  symptoms at these or higher  blood  lead
levels  are  severe gastrointestinal  symptoms and objective  signs of effects on  several other
organ systems.  Precise threshold(s) for occurrence of overt  neurological and gastrointestinal
signs and symptoms of lead exposure in cases  of subencephalopathic lead intoxication remain to
be established, but such effects have been observed in adult  lead workers at blood  lead  levels
as low  as  40-60  ug/dl,  notably lower than levels earlier thought to  be "safe" for adult  lead
exposure.    Other  types of  health  effects  occur coincident  with  the above  overt  neurological
and gastrointestinal symptoms  indicative of  marked lead intoxication.   These  range from  frank
peripheral neuropathies to chronic nephropathy and anemia.
                                           13-32

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                             TABLE 13-7.  SUMMARY OF LOWEST OBSERVED EFFECT LEVELS FOR KEY LEAD-INDUCED HEALTH EFFECTS IN ADULTS
Lowest
effect
100-120

80
60

50

co

30


25-30

15-20

<10
observed *
level (PbB)
ug/dl

ug/dl
ug/dl

ng/di


ug/dl

ug/dl


Mg/di

ug/dl

ug/dl
Heme synthesis and
hematological effects


Frank anemia


Reduced hemoglobin
production

Increased urinary ALA and
elevated coproporphyrins



Erythrocyte protoporphyrin
(EP) elevation in males
Erythrocyte protoporphyrin
(EP) elevation in females
ALA-D inhibition
Neurological Effects on Reproductive Cardiovascular
effects the kidney function effects effects
Encephalopathic signs Chronic
and symptoms nephropathy

-j- 1
1
Overt subencephalopathic '
neurological symptoms
*
Peripheral nerve dysfunction - -
(slowed nerve conduction)
.1.










:emale reproductive
effects
Utered testicular
function

-

Elevated blood
pressure
(White males J
aged 40-59


! i
?
 PbB = blood  lead  concentrations.
Source:  This  report.

-------
     Toward the  lower range of blood  lead  levels  associated with overt lead intoxication  or
somewhat below,  less severe but  important  signs  of impairment in normal physiological  func-
tioning  in several   organ  systems  are evident  among  apparently  asymptomatic  lead-exposed
adults, including the following:   (1)  slowed  nerve conduction velocities indicative of  peri-
pheral  nerve  dysfunction (at  levels as low as 30-40 ug/dl);  (2) altered testicular function
(at 40-50 ug/dl); and (3) reduced hemoglobin  production (at approximately 50  ug/dl) and  other
signs of impaired heme  synthesis  evident at still  lower blood lead  levels.   All  of these ef-
fects point toward a generalized impairment of normal  physiological  functioning  across  several
different  organ  systems, which becomes  abundantly  evident  as adult blood lead levels exceed
30-40 ug/dl.    Evidence  for  impaired heme  synthesis effects  in blood  cells  exists  at  still
lower blood lead levels  in adults, as does  evidence for elevated blood pressure  in middle-aged
white males (aged 40-59).  The significance of impaired heme synthesis effects and evidence  of
impairment of other biochemical processes important in cellular energetics are discussed  below
in relation to children.
13.5.2.2  Children.    Table  13-8 summarizes  lowest observed effect levels for  a  variety of  im-
portant health effects  observed in children.   Again,  as  for  adults,  it can be  seen that lead
impacts many  different  organ  systems  and  biochemical/physiological  processes  across  a wide
range of exposure levels.  Also, again, the most serious of these effects is the severe,  irre-
versible central nervous  system damage manifested in  terms of encephalopathic signs and  symp-
toms.   In  children,  effective  blood lead  levels  for producing  encephalopathy or death  are
lower than for adults, starting at approximately 80-100 ug/dl.  Permanent severe mental retar-
dation and other marked neurological deficits  are among lasting neurological  sequelae typical-
ly seen in cases of non-fatal childhood lead  encephalopathy.   Other overt  neurological  signs
and  symptoms  of subencephalopathic  lead intoxication  are evident in children  at lower  blood
lead levels (e.g., peripheral  neuropathies  detected in some children at levels as  low as  40-60
ug/dl).  Chronic nephropathy,  indexed  by  aminoaciduria,  is most  evident  at high exposure
levels over 100  pg/dl,  but  may also exist at  lower levels (e.g., 70-80 ug/dl).  In addition,
colic and  other  overt gastrointestinal symptoms clearly occur at similar or  still lower  blood
lead levels in children, at least down  to 60 pg/dl.   Frank anemia is  also evident  by 70 ug/dl,
representing  an  extreme manifestation  of  the reduced hemoglobin synthesis observed at  blood
lead  levels as  low  as 40 ug/dl, along  with other signs of marked inhibition  of  heme synthesis
at that exposure level.   All  of  these  effects  are  reflective of the widespread marked impact
of lead on the normal physiological functioning of many different  organ systems  and  some  are
evident in children at blood lead levels as low as 40 ug/dl; and all  of them are widely accep-
ted as being clearly  adverse health effects.
     Additional  studies demonstrate evidence  for further,  important  health  effects  occurring
in  non-overtly  lead-intoxicated  children  at  similar  or lower  blood  lead  levels than  those
                                           13-34

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                     TABLE 13-8.  SUMMARY OF LOWEST OBSERVED EFFECT LEVELS FOR KEV LEAD-INDUCED HEALTH EFFECTS  IN CHILDREN
CO
 I
Lowest observed
effect level (PbB)*
80-100 ug/dl
70 pg/dl
60 ug/dl
50 ug/dl
40 pg/dl
Heme synthesis and
hematological effects

Frank anemia

Reduced hemoglobin
Neurological
effects
Encephalopathic
signs and symptoms

Peripheral neuropathies
Peripheral nerve dysfunction
Renal system
effects
Chronic nephropathy
(aminoaciduria, etc.}



Gastrointestinal
effects
Colic, other overt
gastrointestinal symptoms

.!.

         30 pg/dl


         15 ug/dl


         10 ug/dl
     synthesis

Elevated coproporphyrin

Increased urinary ALA
Erythrocyte protooorphyin
        elevation

AlA-D inhibition

Py-5-Mt activity
   inhibition
        (slowed NCVs)

CHS cognitive effects
  (IQ deficits, etc.)
Altered CMS electrophysiological
            responses
                                                                 Vitamin D  metabolism
                                                                     interference
    *Pbfl = blood lead concentrations.
    tPy-5-N = pyri«idine-5'-nucleot1dase.

    Source:  This report.

-------
indicated above for overt intoxication effects.   Among the most important of  the  effects  dis-
cussed  in Chapter  12  are  neuropsychological and  electrophysiological  effects evaluated  as
being  associated  with  low-level  lead  exposures  in  non-overtly  lead-intoxicated children.
Indications  of peripheral  nerve  dysfunction,  indexed by  slowed  nerve conduction  velocities
(NCV), have  been  shown in children down to  blood  lead levels as  low as  30 ug/dl.   AS  for CNS
effects, none of the available studies on the subject, individually,  can  be said to  prove  con-
clusively that significant cognitive  (IQ)  or behavioral  effects  occur in children at blood
lead levels <30 ug/dl.  However, the most recent neurobehavioral studies  of CNS  cognitive  (IQ)
effects collectively  demonstrate  associations  between neuropsychologic deficits and low-level
lead exposures  in young children resulting in  blood lead levels  ranging to below 30 ug/dl
The magnitudes of  average  observed IQ deficits  generally  appear to  be approxiamtely 5 points
at mean blood  lead levels  of 50-70 pg/dl,  about 4  points  at mean blood  lead levels of 30-50
pg/dl, and  1-2 points at mean blood  lead  levels of 15-30 M9/dl.   Somewhat larger  decrements
have  been reported  for the  latter blood  lead  range among  children  of  lower socioeconomic
status families.
     Additional recent  studies  have  obtained results at blood lead values mainly  in the 15-30
ug/dl range  indicative  of  small,  but not unimportant, effects of  lead  on the  ability to focus
attention, appropriate  social behavior,  and other  types of behavioral performance.  However
due to specific methodological  problems  with each  of these various studies (as  noted in Chap-
ter  12),  much caution  is  warranted  that  precludes  conclusive  acceptance  of the observed
effects being  due  to  lead  rather than other (at times uncontrolled for)  potentially confound-
ing variables.   This caution is  particularly warranted in view of  other well-conducted  studies
that have appeared in the literature which did not  find statistically significant  associations
between lead  and  similar effects at  blood  lead levels  below 30  ug/dl.    Still, because  such
latter  studies even  found  some   small  effects remaining after   correction  for confounding
factors,   lead  cannot  be ruled out as  an etiological  factor contributing to the  induction  of
such effects in the 15-30 ug/dl  range, based on existing published  studies.
     Also of considerable importance  are  studies  which  provide  evidence  of changes  in  EEC
brain wave patterns and CNS  evoked potential responses  in non-overtly lead intoxicated chil-
dren.   The work of  Burchfiel  et al.  (1980)  indicates  significant  associations  between IQ de-
crements,  EEG  pattern  changes,   and  lead  exposures  among children with average blood  lead
levels falling in  the range  of  30-50  vg/tf.   Research  results  provided  by Otto et  al. (1981,
1982, 1983)  also demonstrate clear, statistically significant associations between electrophy-
siological (SW voltage)  changes and blood lead  levels in  the range  of 30-55  ug/dl  and analo-
gous associations at  blood  lead levels below 30 pg/dl  (with  no evident  threshold down to  15
ug/dl or somewhat lower).  In this case,  the presence of electrophysiological  changes observed

                                           13-36

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upon follow-up of some  of  the same children two years  and five years later suggests persis-
tence of such effects even in the face of later declines  in blood  lead  levels  and,  therefore,
possible long-term persistence of the observed  electrophysiological  CMS  changes.   However,  the
reported electrophysiological effects  in  this  case were not found  to  be significantly associ-
ated with IQ decrements.
     While the precise  medical  or health significance of  the  neuropsychological  and electro-
physiological effects  found by the  above  studies  to be associated with  low-level  lead  expo-
sures is difficult  to  fully define at this time, the IQ deficits and  other behavioral changes
likely  impact the  intellectual  development, school performance, and social development  of the
affected children  sufficiently so as  to  be regarded as adverse.  This  is  especially true if
such  impaired intellectual  development or  school performance and disrupted social development
are reflective of persisting, long-term effects of low-level lead exposure in early childhood.
The  issue  of persistence of such lead effects still remains to be more clearly resolved, with
some  study results  reviewed in Chapter  12 and mentioned above suggesting relatively  short-
lived  or markedly  decreasing  lead  effects on neuropsychological   functions over a few years
from  early to  later childhood and other  studies  suggesting that  significant  low-level  lead-
induced neurobehavioral and EEC effects  may,  in fact,  persist into  later childhood.  Despite
any  remaining ambiguities  of the above type,  however,  the medical community  has highlighted
(CDC, 1985)  lead-induced neurobehavioral  effects (e.g.,  IQ deficits and  other  neuropsychologic
effects) as  one  basis for  viewing  pediatric blood  lead  levels  below 25-30 ug/dl as being asso-
ciated  with  unacceptable risk for  lead-induced toxicity.
      In regard  to  additional  studies reviewed  in  Chapter 12 concerning the  neurotoxicity of
lead,  certain evidence exists which  suggests  that  neurotoxic effects  may be associated  with
lead-induced alterations in heme synthesis, resulting in an accumulation of ALA in  brain which
affects CNS GABA synthesis,  binding,  and/or inactivation by  neuronal  reuptake after synaptic
release.   Also,  available experimental  data  suggest that  these  effects may have  functional
 significance in the terms of this  constituting one mechanism by  which  lead  may  increase the
 sensitivity of  rats to drug-induced seizures  and,  possibly,  by which  GABA-related behavioral
 or physiological control  functions  are disrupted.   Unfortunately, the  available  research data
 do not allow credible  direct estimates of blood lead levels at which such effects might occur
 in rats,  other non-human  mammalian species,   or  man.   Inferentially,  however,  one can state
 that threshold  levels  for any marked lead-induced  ALA impact on  CNS GABA mechanisms  are most
 probably at  least  as  high as blood lead levels at which  significant accumulations of ALA have
 been detected  in  erythrocytes or non-blood soft tissues  (see below).  Regardless of any  dose-
 effect levels inferred, though, the functional and/or medical significance of lead-induced ALA
 effects on  CNS  mechanisms at low levels  of lead  exposure  remains to be more fully determined
 and cannot, at  this time,  be unequivocably seen as  an  adverse health effect.
                                             13-37

-------
     Research concerning lead-induced effects  on  heme synthesis also provides information of
importance in evaluating what blood lead levels are associated  with  significant health effects
in children.   As discussed  earlier,  in  Chapter 12 and Section  13.4,  lead affects heme synthe-
sis at several points in its metabolic pathway, with consequent impact on the  normal function-
ing of many body tissues.   The activity  of the enzyme ALA-S,  catalyzing  the  rate-limiting step
of heme synthesis, does  not appear to be significantly affected until blood lead levels reach
or exceed approximately 40  ug/dl.   The  enzyme ALA-D, which catalizes the conversion of ALA to
porphobilinogen as a  further  step  in the heme biosynthetic pathway,  appears to be  affected at
much  lower blood  lead levels as indexed  directly  by observations  of ALA-D inhibition or in-
directly  in  terms  of  consequent  accumulations of  ALA in blood and non-blood tissues.  More
specifically, inhibition of erythrocyte  ALA-D  activity has been observed in  humans and other
mammalian species at  blood lead levels  even below  10-15  ug/dl, with no clear threshold evi-
dent.  Correlations between erythrocyte  and  hepatic ALA-D activity  inhibition in lead workers
at blood  lead levels  in the range of 12-56  ug/dl  suggest that ALA-D activity in soft tissues
(e.g., brain, liver,  kidney, etc.)  may be inhibited at similar  blood lead  levels at which ery-
throcyte ALA-D activity inhibition occurs, resulting in accumulations of ALA in both blood and
soft tissues.
     Some studies indicate  that increases in both blood  and urinary ALA  occur below the cur-
rent commonly-accepted blood  lead  level  of 40 ug/dl.  Such increases in blood and  urinary ALA
are detectable  in humans  at blood lead  levels below 30 ug/dl,  with  no clear threshold  evident
down to 15-20 ug/dl,  although other data exist which fail  to  show  any relationship below 40
ug/dl  blood   lead.   Other  studies  have  demonstrated  significant  elevations in  rat brain,
spleen, and kidney ALA levels consequent to acute or chronic lead exposure,  but no  clear blood
lead levels can yet be specified at which such non-blood tissue ALA  increases occur in  humans.
It is  reasonable to  assume, however, that ALA  increases  in non-blood  tissues likely begin to
occur  at  roughly  the same  blood  lead  levels associated with  increases  in erythrocyte ALA
levels.
     Lead also  affects heme  synthesis  beyond metabolic  steps involving  ALA, leading to the
accumulation  of porphyrin in erythrocytes as  the result  of impaired iron  insertion into the
porphyrin moiety to  form heme.   The porphyrin acquires a zinc  ion in lieu of the  native  iron,
and  the  resulting accumulation of blood zinc protoporphyrin  (ZPP)  tightly  bound  to  erythro-
cytes  for their entire life (120  days)  represents  a commonly  employed  index of  lead  exposure
for  medical  screening purposes.   The threshold  for elevation of  erythrocyte  protoporphyrin
(EP)  levels  is  well-established as being 25-30 ug/dl in adults and  approximately  15 ug/dl  for
young  children, with  significant  EP elevations (>l-2 standard  deviations  above reference  nor-
mal  EP mean  levels)  occurring in  50  percent of  all children studied as blood lead approaches
or moderately exceeds 30 ug/dl.
                                           13-38

-------
     Medically, small  increases  in EP  levels  were previously  not viewed  as  being of  great
concern at  initial  detection levels  around 15-20 ug/dl  in children.  However, EP  increases
become more worrisome when markedly greater, significant elevations occur  as blood  lead  levels
reach 20  to 30 ug/dl and additional  signs  of  significantly deranged heme  synthesis begin  to
appear, along with indications of functional disruption of various  organ systems.   Previously,
such  other  signs  of  significant organ system  functional  disruptions had  only been  credibly
detected at blood lead levels distinctly in excess of 30 ug/dl,  e.g.,  inhibition of hemoglobin
synthesis  starting  at 40 ug/dl  and  significant nervous system effects at  50-60 ug/dl.   This
served  as a basis  for CDC's 1978 statement establishing  30  ug/dl blood  lead as  a  criteria
level for undue lead exposure for young children.   At the present time,  however,  the medical
community  (CDC, 1985) accepts EP elevations associated with PbB  levels of 25 ug/dl or higher
as being  unacceptable in pediatric populations.
      Recently,  it has also  been demonstrated  in children  that lead  is negatively correlated
with  circulating  levels  of the  vitamin D  hormone, 1,25-dihydroxyvitamin  D, with  the negative
association existing down to 12 ug/dl  of  blood lead.  This effect of lead is of considerable
significance  on two counts:   (1)  altered  levels of  l,25-(OH)2-vitamin D  not only impact cal-
cium  homeostasis  (affecting  mineral metabolism,  calcium  as a second messenger, and calcium as
a  mediator of cyclic nucleotide metabolism) but also likely impact  its  known role in immuno-
regulation  and mediation of  tumorigenesis;  and (2)  the effect of  lead on l,25-(OH)2-vitamin D
is a particularly robust one, with  blood  lead  levels of  30-50 ug/dl  resulting  in decreases in
the  hormone that overlap comparable  degrees of decrease seen in  severe  kidney injury or cer-
tain  genetic diseases.
      Erythrocyte  Py-5-N  activity  in  children  has also been demonstrated to be negatively  im-
pacted by  lead at exposures  resulting in blood  lead levels markedly below 30  ug/dl (i.e., to
 levels below 5 ug/dl with no evident threshold).  Extensive reserve  capacity  exists for this
 blood enzyme,  such that  it is not markedly depleted  until blood lead  levels reach  approximate-
 ly 30-40 ug/dl,  arguing  for the Py-5-N effect  in and of itself  as perhaps not being particu-
 larly adverse  until such blood lead  levels are reached.   However, the  observation of  Py-5-N
 inhibition is more  arguably  indicative of more widespread impacts on pyrimidine metabolism in
 general in additional organs and tissues besides blood, such that lead exposures  lower  than 30
 ug/dl resulting in measurable Py-5-N inhibition in erythrocytes may be of greater  medical  con-
 cern when viewed from this broader perspective.
      Also  adding to the  concern about relatively low exposure levels of  lead are the results
 of an  expanding  array of animal toxicology studies which demonstrate the  following:   (1) per-
 sistence   of   lead-induced   neurobehavioral  alterations  well   into  adulthood   long  after
 termination  of  perinatal  lead exposure  early in  development  of several  mammalian species;

                                            13-39

-------
(2) evidence for uptake  and  retention  of lead in neural  and non-neuronal  elements  of  the CNS,
including long-term persistence  in  brain tissues after termination of external  lead  exposure
and blood lead  levels  have  returned to "normal"; and (3)  evidence  from various  in  v ivo and  \n
vitro studies  indicating that,  at  least on  a subcellular-molecular level, no  threshold may
exist for certain neurochemical effects of lead.
     Given  the  above  new evidence  that  is  now available, indicative of  significant  lead ef-
fects on nervous system  functioning and other important  physiological processes as blood lead
levels increase above  15-20  ug/dl  and  reach 20 to 30  ug/dl,  the rationale  for  considering  30
pg/dl as  a  "maximum safe"  blood lead  level  (as was  the case  in  setting  the  1978  EPA lead
NAAQS) was  called  into  question and substantial  impetus provided for revising the  criteria
level downward.   At  this  time,  it is  difficult to  identify  specifically  what  blood lead
criteria level  would  be appropriate in view  of the  existing medical information.   Clearly,
however, 30 ug/dl  does  not  afford any margin  of  safety  before blood lead  levels  are reached
that are associated with unacceptable risk of notable adverse health effects occurring in some
children.   This is based on  at  least two grounds:   (1)  blood lead levels  in the  30-40 ug/dl
range are  now  known  to "mask", for  some  children,  markedly elevated  chelatable body lead
burdens  that are comparable  to lead burdens seen in  other children displaying overt  signs and
symptoms of  lead intoxication  and  (2)  blood  lead levels  in the 30-40 ug/dl  range  are also
associated with  the  onset of  deleterious effects in  several organ systems which are either
individually or collectively seen  as being adverse.    These  and  other considerations  have led
the medical  community  (CDC,  1985)  to define 25 ug/dl PbB as a level associated  with  unaccept-
able risk for pediatric lead toxicity.
     At  levels  below  25-30  ug/dl,  many of  the  different  smaller  effects  reported  as being
associated with lead exposure  might be argued as separately not  being of clear medical signi-
ficance, although each are  indicative  of interference by lead with normal  physiological pro-
cesses.   On  the other  hand,  the collective impact of  all  of the observed  effects (representing
potentially  impaired functioning and depleted reserve capacities  of many  different  tissues and
organs)  can, at some  point distinctly below  25-30 ug/dl, be seen  as representing an adverse
pattern  of  effects worthy   of  avoidance.   The  onset  of  signs  of detectable  heme  synthesis
impairment in many different organ systems at blood lead levels starting around 10-15 pg/dl,
along with  indications of  increasing degrees of pyrimidine  metabolism  interference  and  signs
of altered  nervous system activity, might be  viewed as  such a point.   Or,  alternatively, the
collective impact of such effects  might be argued as becoming sufficiently  adverse to warrant
avoidance (with  a  margin of safety) only  when  the  various effects come to  represent marked
deviations from normal  as blood lead levels exceed 20-25  ug/dl.
                                           13-40

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     The  frequency  of  occurrence  of various  effects  among  individual  affected children  at
various blood lead  levels  may  have important bearing on the  ultimate  resolution of  the  above
issue regarding the definition  of  blood lead levels  associated  with  adverse  health effects  in
pediatric populations.   The proportion of children likely affected (i.e.,  responders) in  terms
of experiencing particular  types of effects at various  lead  levels  is also  an important con-
sideration.   Some information bearing on this latter  point  is  discussed next.
13.6  DOSE-RESPONSE RELATIONSHIPS FOR LEAD EFFECTS IN HUMAN POPULATIONS
     Information summarized in the preceding section dealt with the various biological effects
of  lead  germane to the general  population  and included comments about the  various  levels  of
blood  lead  observed to  be associated with  the measurable onset of these  effects  in various
population groups.  As  indicated above,  inhibition of ALA-D activity by lead occurs at virtu-
ally all  blood lead levels measured in subjects residing in industrialized countries.  If any
threshold for  ALA-D inhibition exists, it lies  somewhere below 10 pg/dl blood lead.
     Elevation in  erythrocyte protoporphyrin for a given blood lead level is greater in chil-
dren  and women than in  adult males,  children being somewhat  more  sensitive than women.   The
threshold for  currently detectable EP elevation in terms of blood lead levels for children was
estimated  at approximately 16-17 (jg/dl  in  the recent studies of  Piomelli  et al.  (1982).   In
adult  males,  the corresponding  blood lead value  is 25-30 ug/dl.  Also, statistically signifi-
cant  reduction in  hemoglobin production occurs  at a lower blood  lead  level in children (40
ug/dl) than  in adults  (50  ug/dl).
     Coproporphyrin elevation in urine first occurs at  a blood lead  level of 40 ug/dl and this
threshold appears  to apply for both children and adults.   In addition, it appears that urinary
ALA shows a correlation with blood  lead levels to  below 40 ug/dl,  but since there  is no clear
agreement as  to  the  meaning of elevated ALA-U  below 40 ug/dl,  this value  is  taken as the
threshold for  pronounced  excretion of  ALA into urine.  This value appears to apply to both
children and  adults.   Whether this  blood lead level represents a  threshold for  the potential
 neurotoxicity of circulating ALA cannot  now be stated and  requires  further  study.
      A number  of  investigators  have  attempted to quantify more precisely  dose-population  re-
 sponse relationships for  some of the above lead effects  in  human populations.   That is,  they
 have attempted to  define  the proportion of  a population  exhibiting a particular  effect at  a
 given blood  lead  level.   To date,  such  efforts at defining dose-response relationships  for
 lead effects  have  been  mainly  limited to the following  effects of lead on heme biosynthesis:
 inhibition of  ALA-D activity; elevation of EP; and urinary excretion of ALA.
                                            13-41

-------
     Dose-population response relationships  for  EP  in children have been analyzed in detail  by
Piomelli  et  al.  (1982) and  the corresponding plot at  two levels of elevation (>1 S.D.,  >2
S.D.) is shown in Figure 13-5 using probit analysis.  It can be seen that blood lead levels  in
half of  the  children  showing EP elevations  at >1 and 2 S.D.'s closely bracket the  blood  lead
level taken  as the  high end  of "normal"  (i.e., 30 ug/dl).   Dose-response curves for adult men
and women as  well  as  children prepared by Roels et al.  (1976) are  set  forth  in Figure 13-6.
In Figure 13-6,  it  may be seen that the  dose-response for children remains greater  across the
blood lead range  studied,  followed  by women, then adult males.
     Figure 13-7  presents dose-population response data for urinary ALA  exceeding  two levels
(at mean  + 1 S.D.  and mean  + 2 S.D.), as  calculated  by EPA from  the data of Azar et al.
(1975).   The percentages of  the  study  populations  exceeding the  corresponding cut-off levels
as calculated by EPA  for  the Azar  data are  set forth in Table 13-9.   It should be  noted  that
the measurement of ALA  in  the Azar et  al.  study did not  account  for  aminoacetone,  which may
influence the results  observed at the lowest blood lead levels.
                99

                95
                90

                76
             O
             I-
             §  10
             E   6
                                                      2SD
                        O	^
                          • f
          NATURAL FREQUENCY   __
                                                I
10
20
   30     40
BLOOD LEAD,
                                                       60
60
70
                   Figure 13-5.  Dose-response for elevation of EP as a
                   function of blood lead level using probit analysis .
                   Geometric mean plus 1 S.D.  « 33 MQ/dl; geometric mean
                   plus 2 S.D.  « 53
                  Source:  Piomelli et al. (1982).
                                          13-42

-------
  100
   •0 -
   40
&

I  »
                                     ADULT FEMALES
     ADULT MALES
               10        20       30

                    BLOOD LEAD LEVEL, pg/dl
                                            40
                                                      BO
       Figure 13-6.  Dose-response curve for FEP as e function
       of blood lead level: in eubpopulations.
       Source: Roels et et. (1976).
    W10U
    i-
    A M
    1-
       M


       M



       40


       30



       20


       10
             I     I    I
I     I    I    I    7
o MEAN +1 5.0.
AMEAN+2S.D.
  MEAN ALA-U - 0.32 FOR .
   BLOOD LEAD <13M/dl

 I
             10   20    JO   40   M   CO   70

                     BLOOD LEAD LEVEL. pg/dl
                                              •o
                                                  so
      Figure 13-7.  EPA-calculited do*e-r*sponte curve for ALA-U.

      Source:  Anretsl. (1975).

                       13-43

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                      TABLE 13-9.   ERA-ESTIMATED PERCENTAGE OF SUBJECTS
                   WITH ALA-U EXCEEDING LIMITS FOR VARIOUS BLOOD LEAD LEVELS
             Blood lead levels,                                  Azar et al.  (1975),
                  |jg/dl                                         percent population
                    10                                                 2
                    20                                                 6
                    30                                                16
                    40                                                31
                    50                                                50
                    60                                                69
                    70                                                84
13.7  POPULATIONS AT RISK
     A  population  at risk  is a  segment  of a  defined population exhibiting  characteristics
associated with  significantly  higher  probability of developing a condition,  illness,  or other
abnormal status.   This high risk may result from either (1) greater inherent susceptibility or
(2) from exposure situations peculiar to that group.  What is meant by inherent susceptibility
is a  host  characteristic  or status that predisposes  the  host to a greater risk of heightened
response to an external  stimulus or agent.
     In regard to lead,  three such populations are definable:  they are preschool age children
(^6 years  old),  especially  those living  in  urban settings, pregnant women,  and  white males
aged 40-59, although  the  evidence concerning this latter group is much more limited than that
for the other two.   Children are  such  a population  for both of  the reasons  stated  above,
whereas pregnant women  are at risk primarily  due to the  inherent susceptibility  of  the con-
ceptus.   Also,  for reasons  not  as yet  fully  understood,  the limited  information available
indicates  that  middle-aged white  males  appear  to  be differentially  more at  risk for mani-
festing elevations  in blood pressure in response to lead exposure (see the Addendum to this
document for a complete discussion of the evidence supporting this).

13.7.1  Children as a Population at Risk
     Children are  developing  and growing organisms exhibiting certain differences from adults
in  terms  of basic  physiologic mechanisms, capability of  coping  with  physiologic  stress, and
their  relative metabolism of lead.  Also, the  behavior  of children frequently places them in
different  relationship  to sources of lead in  the environment,  thereby enhancing the opportu-
nity  for  them  to absorb  lead.  Furthermore, the  occurrence of excessive exposure often  is not
                                           13-44

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realized until  serious harm is done.   Young children do not readily communicate  a  medical  his-
tory of lead exposure,  the early signs of  such  being  common to so many other  disease  states
that lead is frequently not recognized early on as a possible etiological  factor  contributing
to the manifestation of other symptoms.
13.7.1.1  Inherent Susceptibility of the Young.   Discussion of the physiological vulnerability
of the young must address two discrete areas.  Not only should the basic physiological  differ-
ences be considered that one would expect to predispose children to a heightened vulnerability
to lead,  but also the actual clinical evidence must be considered that shows such vulnerabil-
ity does indeed exist.
     In Chapter  10  and Section 13.2  above,  differences  in relative exposure to lead and body
handling of lead  for children versus  adults were pinpointed throughout the text.  The signifi-
cant elements  of difference include  the following:  (1) greater intake of lead by infants and
young  children into the  respiratory  and gastrointestinal  (GI) tracts  on  a  body  weight basis
compared  to  adults; (2) greater absorption  and retention  rates of lead in children; (3) much
greater prevalence  of nutrient deficiency  in the  case of nutrients which affect lead absorp-
tion  rates  from  the  GI tract; (4) differences  in certain habits, i.e., normal hand-to-mouth
activity  as  well as pica,  resulting  in  the transfer of  lead-contaminated  dust  and dirt to the
GI  tract; (5) differences  in the  efficiency of lead  sequestration in the bones  of children,
such  that not  only is  less of the  body burden  of lead in bone  at  any  given time,  but the
amount present may be  relatively  more labile.   Additional  information discussed  in  Chapter 12
suggests  that  the blood-brain  barrier  in  children  is  less developed,  posing  the risk for
greater entry  of lead into the nervous system.
      Hematological  and neurological  effects  in children have been demonstrated to  have  lower
thresholds  in  terms of blood lead levels than  in adults.   Similarly, reduced  hemoglobin pro-
duction and EP  accumulation  occur  at relatively lower exposure  levels  in children  than  in
adults, as indexed by blood lead thresholds.   With reference to neurologic  effects, the onset
 of encephalopathy and other injury to the nervous system appears to vary both regarding likely
 lower thresholds in children for some effects and in the typical pattern of  neurologic effects
 presented,  e.g., in  encephalopathy  or other CMS deficits being more common  in  children versus
 peripheral  neuropathy being more often seen in adults.  Not only are the effects  more  acute in
 children than  in  adults,  but the neurologic  sequelae are  also usually much more severe in
 children.
 13.7.1.2  Exposure Consideration.  The  dietary habits of children as well  as  the diets them-
 selves differ markedly from adults  and,  as  a  result, place children  in  a different relation-
 ship  to  several  sources of  lead.  The dominance  of canned milk and processed  baby  food  in the
 diet  of  many  young children  is an important factor in  assessing  their exposure to  lead, since

                                             13-45

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both those foodstuffs have been shown to contain higher amounts of lead than components of the
adult diet.  The  importance  of these lead sources  is  not their relationship to airborne lead
directly but,  rather,  their  role in providing a higher baseline lead burden to which the air-
borne contribution is added.
     Children ordinarily  undergo  a  stage of development in which they exhibit normal mouthing
behavior, as manifested,  for example,  in the form  of  thumbsucking.   At this time they are at
risk for picking up lead-contaminated soil and dust on their hands and hence into their mouths
where it can be absorbed.
     There is,  however, an  abnormal  extension of mouthing behavior,  called pica, which occurs
in  some  children.   Although diagnosis of  this  is difficult, children who  exhibit  this  trait
have been  shown to purposefully eat nonfood  items.  Much of the lead poisoning  due to  lead-
based paint is known to occur because children actively ingest chips  of leaded paint.

13.7.2  Pregnant Women and the Conceptus as a Population at Risk
     There are  some  rather  inconculsive data indicating that women may in general be at some-
what higher  risk  to  lead  than men.   However, pregnant women and their concepti as a subgroup
are  demonstrably  at higher  risk.   It should  be noted  that,  in fact,  it really  is  not the
pregnant woman  per s_e  who is at  greatest  risk  but, rather, the unborn child she is carrying.
Because  of obstetric  complications, however,  the  mother  herself  can  also  be  at somewhat
greater risk at the time of delivery of her child.  With reference to maternal complication at
delivery,  information  in  the  literature  suggests that the  incidence  of  preterm delivery and
premature membrane  rupture  relates  to maternal  blood lead level.  Further study of this rela-
tionship as  well   as  studies relating to  discrete  health effects in  the newborn are needed.
     Vulnerability of the developing fetus to lead exposure arising from transplacental trans-
fer of maternal lead was discussed in Chapter 10.  This process starts at the end of the first
trimester.   Umbilical cord blood studies involving mother-infant pairs have repeatedly shown a
correlation between maternal and fetal blood lead levels.
     Further suggestive  evidence, cited  in  Chapter 12,  has been advanced for prenatal lead
exposures of fetuses,  possibly leading to later higher instances of postnatal mental retarda-
tion among the affected offspring.  The available data are insufficient to state with any cer-
tainty that such effects occur or to determine with any precision what levels of lead exposure
might be required  prior to or during pregnancy in order to produce such effects.
     Studies have  demonstrated that women in general,  like children,  tend to show a  heightened
response of  erythorcyte protoporphyrin  levels  upon exposure  to lead.   The exact reason for
this heightened  response  is not known but may relate to endocrine differences between men and
women.
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13.7.3  Middle-Aged White Males (Aged 40-59)  as a Population at Risk
     Recently-emerging epidemiological  evidence  indicates  that  increased  blood pressure  is
associated with blood  lead  concentrations  ranging from >30-40 ug/dl  down to blood lead levels
possibly as  low as  7  ug/dl.   This  relationship appears to  be particularly  significant  for
middle-aged white males  (aged  40-59),  although a considerable degree of uncertainty surrounds
the statistical analyses  of the  studies giving  rise to  this  conclusion.  A detailed critique
of  the  various analyses  which have been  performed on the available  epidemiological  studies
concerning the  blood lead/blood  pressure relationship, as well  as  a discussion of the plaus-
ible  biological  mechanisms  underlying  this  relationship, are  presented in Section  1 of  the
Addendum to this document.
     The specific  magnitudes  of  risk obtained for serious cardiovascular outcomes in relation
to  lead exposure,  estimated  on the  basis of  lead-induced  blood pressure  increase,  depends
crucially  upon  the size of the coefficients estimated for the blood lead/blood pressure asso-
ciation.   Given the  fact  that  significant  uncertainty exists  in  regard to the most appropriate
blood-lead blood-pressure  coefficient(s)  to  use  in attempting  to  project serious cardiovas-
cular  outcomes,  the further analysis of additional  large-scale  epidemiological data sets will
be  necessary  in order  to  resolve more precisely  the quantitative relationship(s)  between blood
lead  and  blood pressure.   It is  possible,  however, to  identify at this time the population
subgroup of middle-aged white  males  (aged  40-59)  as being yet another  group at general risk in
terms  of manifesting notable  health  effects  in response  to  lead  exposure.

13.7.4  Description of the  United  States Population in Relation  to  Potential
         Lead  Exposure  Risk
      In this  section,  estimates  are  provided of the number  of individuals in those  segments of
the population which  have  been  defined as being  potentially at greatest risk for lead expo-
sures.   These  segments  include preschool children (up  to  6 years of  age),  especially those
 living in urban settings,  women  of child-bearing age  (defined  here as ages 15-44),  and white
males, aged  40-59.   These data,  which are presented  in  Table 13-10,  were  obtained from  a
provisional  report  by the  U.S.  Bureau of the  Census  (1984).  Data from the 1980 Census  (U.S.
 Bureau of the  Census,  1983)  indicates that approximately  61 percent of the populace lives in
 urban areas  (defined  as  central  cities and  urban fringe).   Assuming that the  61 percent esti-
 mate  for  total urban  residents  applies  equally  to children of preschool  age,  then approxi-
 mately 15,495,000  children of  the  total  listed  in Table  13-10 would  be  expected  to be at
 greater risk by virtue  of higher  lead  exposures generally associated with  their  living  in
 urban  versus non-urban  settings.   (NOTE:  The  age distribution  of the  percentage  of urban
 residents may vary  between SMSA's.)

                                            13-47

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         TABLE 13-10.   PROVISIONAL ESTIMATE OF  THE NUMBER  OF  INDIVIDUALS  IN  URBAN AND
             RURAL POPULATION SEGMENTS AT GREATEST POTENTIAL  RISK  TO  LEAD EXPOSURE
Population segment
Preschool children
Total
Women of
child-bearing age
Total
White males
Total
Actual age,
(yr)
0-4
5
6
15-19
20-24
25-29
30-34
35-39
40-44
40-44
45-49
50-54
55-59
Total number in U.S.
population
(1984)
18,453,000
3,576,000
3,374,000
25,403,000
9,019,000
10,481,000
10,869,000
10,014,000
9,040,000
7,179,000
56, 602, bOO
6,064,000
4,960,000
4,600,000
4,760,000
20,384,000
Urban
population*
11,256,000
2,181,000
2,058,000
15,495,000
5,502,000
6,393,000
6,630,000
6,109,000
5,514,000
4,379,000
34,527,000
3,699,000
3,026,000
2,806,000
2,904,000
12,435,000
*An urban/total ratio of 0.61 was used for all  age groups.   "Urban" includes central  city
 and urban fringe populations (U.S.  Bureau of the Census,  1983).
Source:   U.S.  Bureau of the Census (1984), Table 6.
     The  risk encountered with  exposure to  lead  may be  compounded by  nutritional  deficits
(see Chapter  10).   The  most  commonly seen  of  these is iron deficiency, especially  in  young
children  less  than  5 years of age  (Mahaffey and Michael son, 1980).  Data available  from  the
National Center  for  Health Statistics for 1976-1980 (Fulwood et al., 1982)  indicate that from
8 to 22  percent  of  children aged 3-5 may exhibit iron deficiency, depending upon whether this
condition  is  defined as  serum iron  concentration  (<40 ug/dl)  or as  transferrin  saturation
(<16 percent), respectively.   Hence, of the 22,029,000 children £5 years of  age (Table 13-10),
as many as 4,846,000 would be expected to be at increased risk, depending on their exposure to
lead, due to iron deficiency.
     As pointed out in Section 13.7.2, the risk to pregnant women is mainly  due to risk to the
conceptus.  By dividing the total  number  of women of child-bearing age  in  1981 (56,602,000)
into the total number of  live births  in 1984 (3,697,000;  National  Center  for Health Statis-
tics, 1985), it may be seen that approximately 7 percent of this segment of  the population may
be at increased risk at any given time.
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     As for white males,  aged 40-59,  defined as being at risk most notably  for  increased  blood
pressure in association with  elevated  blood lead levels,  approximately  20  million  individuals
can be estimated to be at potential  risk based on the 1980 U.S.  Census data.
13.8  SUMMARY AND CONCLUSIONS
     Among  the  most significant  pieces  of information  and conclusions that emerge  from  the
present human health risk evaluation are the following:

     (1)  Anthropogenic  activity has  led  to  vast  increases  of  lead input into  those
          environmental  compartments which  serve as media (e.g., air, water, food,  dust,
          and  soil,  etc.) by  which significant human exposure  to  lead occurs.   Current
          blood  lead  concentrations  of populations  in  industrialized  societies  best
          reflect  this  impact of  man's activities,  with such  lead  levels being  much
          higher  than  those  found  in  contemporary  populations remote  from industrial
          activities.

      (2)  Emission  of lead  into  the atmosphere,  especially through leaded gasoline com-
          bustion,  is  of  major  significance  in terms of  both  the movement of lead to
          other environmental  compartments and  the  relative  impact of such emissions on
          the  internal  lead burdens  in  industrialized  human populations.   By  means of
          both mathematical  modeling  of available  clinical/epidemiological  data by  EPA
          and  the  isotopic tracing  of  lead  from gasoline  to the  atmosphere to human blood
          of exposed populations,  the atmospheric  lead  contribution to human blood  lead
           levels in industrialized  areas  is  estimated to be  approximately 25-50 percent.

      (3) Given this  magnitude of  relative  contribution to human  external and internal
           exposure, decreases in atmospheric  lead levels would then result in significant
          widespread reductions in levels of  lead in human blood (an outcome supported by
           careful  analysis  of the  NHANES II  data).  Reduction  of  lead in food (added in
           the  course  of harvesting,  transport, and processing)  is also  be expected to
           produce  significant widespread  reductions  in  human  blood  lead levels  in the
           United States,  as  would efforts to decrease the  numbers of American children
           residing in housing with interior or exterior lead-based  paint.
                                            13-49

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(4)  A number of adverse  effects  in humans  and other species  are clearly associated
     with lead  exposure  and, from  an historical  perspective, the observed  "thres-
     holds"  for these various effects (particularly neurological  and  heme biosynthe-
     sis effects) continue to decline as  more sophisticated experimental and clini-
     cal measures are employed to  detect more subtle, but still  significant effects.
     These  include  significant  alterations  in  normal  physiological  functions  at
     blood lead  levels markedly below the currently accepted  25 ug/dl  "maximum safe
     level"  for pediatric exposures.

(5)  Preceding  chapters  of  this  document  demonstrate that  young  children  are  at
     greatest risk for experiencing  lead-induced health effects,  particularly in the
     urbanized, low-income segments  of this  pediatric population.  A  second group at
     increased risk is pregnant women,  because of exposure of  the  fetus to  lead in
     the absence of  any effective  biological (e.g., placental) barrier  during gesta-
     tion.   A  third group at  increased risk  would appear to be white  males,  aged
     40-59,  in  that  blood pressure  elevations appear to be significantly correlated
     with elevations in blood lead level in this group.

(6)  Dose-population response  information for heme  synthesis effects,  coupled with
     information from various blood  lead  surveys, e.g., the  NHANES  II  study, indi-
     cate that  large  numbers  of  American  children (especially low-income,  urban
     dwellers) have blood  lead  levels sufficiently  high (in  excess  of  15-20 ug/dl)
     that they  are  clearly at risk for deranged heme synthesis and,  possibly, other
     health  effects  of growing concern as  lead's role as a general systemic  toxicant
     becomes more completely  delineated.
                                      13-50

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13.9  REFERENCES


Angle, C.  R.;  Marcus,  A.;  Cheng, I.-H.; Mclntire, M. S. (1984) Omaha childhood blood lead and
     environmental lead: a linear total exposure model. Environ. Res. 35: 160-170.

Angle, C.  R.;  Mclntire,  M.  S.  (1979) Environmental  lead  and children:  the Omaha study. J.
     Toxicol. Environ. Health 5: 855-870.

Annest, J. L.; Mahaffey, K. R.; Cox, D. H.; Roberts, J. (1982)  Blood  lead  levels  for persons  6
     months-74  years of  age:  United  States,  1976-80. Hyattsville,  MD: U.  S.  Department of
     Health  and  Human  Services;  DHHS pub no.  (PHS)  82-1250.  (Advance data  from vital and
     health  statistics of  the National Center  for  Health Statistics:  no. 79).

Azar,  A.;  Snee,  R.  D. ; Habibi,  K.  (1975) An  epidemic logic  approach  to  community air lead ex-
     posure  using  personal  air  samplers. In:  Griffin,  T.  B.;  Knelson, J.  H., eds.  Lead.
     Stuttgart,  West Germany:  Georg Thieme Publishers; pp.  254-290.  (Coulston,  F.;  Korte, F.,
     eds.  Environmental quality  and  safety: supplement v.  2).

Billick,  I.  H. ; Curran, A. S.;  Shier, D.  R.  (1979)  Analysis of pediatric  blood lead levels  in
     New  York  City  for  1970-1976.  Environ.  Health  Perspect.  31: 183-190.

Brunekreef,  B.  D.  (1984)  The  relationship  between  air  lead and  blood   lead  in children:  a
      critical  review.  Sci.  Total  Environ.  38:  79-123.

Burchfiel, J.  L.; Duffy,  F.  H.; Bartels, P.  H.;  Needleman,  H.  L.  (1980) The combined discrim-
      inating power  of quantitative  electroencephalography  and  neuropsychologic  measures  in
      evaluating central  nervous system effects of  lead  at  low levels.  In:  Needleman,  H.  L.,
      ed.  Low level  lead exposure:  the clinical implications  of current research. New York, NY:
      Raven Press; pp.  75-89.

Chamberlain, A. C.;  Heard, M.  J.;  Little, P.; Newton,  D.;  Wells, A. C.;  Wiffen, R. D. (1978)
      Investigations  into  lead from  motor vehicles.  Harwell,  United Kingdom:  United  Kingdom
      Atomic Energy Authority; report no.  AERE-R9198.

 Facchetti,  S.  (1985) Isotopic  lead experiment -  a  update.  Presented  at: Lead environmental
      health: the current  issues;  May; Durham, NC. Durham, NC: Duke University Medical  Center.

 Facchetti,  S.;  Geiss,  F.  (1982)   Isotopic  lead  experiment:   status   report.  Luxembourg:
      Commission of the European Communities;  Publication no. EUR 8352 EN.

 Fulwood,  R.;  Johnson,  C.  L.;  Bryner,  J.  D.; Gunter,  E.  W.; MacGrath,  C.  R.  (1982) Hemato-
      logical  and nutritional biochemistry reference  data for persons  6  months - 74 years  of
      age:  United States,  1976-80.   Hyattsville,  MD:  U.  S.   Department  of Health  and  Human
      Services,  National   Center  for  Health   Statistics;  DHHS publication no.   (PHS)  83-1682.
      (National  health survey series 11,  no. 232).

 Griffin,  T. B.; Coulston, F.; Golberg,  L.;  Wills,  H.; Russell,  J.  C.; Knelson, J. H.  (1975)
      Clinical  studies  on  men continuously exposed  to airborne particulate  lead.  In:  Griffin,
      T.  B.;  Knelson,  J.  H. ,  eds. Lead.  Stuttgart,  West Germany:  Georg Thieme Publishers;  pp.
      221-240.  (Coulston,  F.; Korte,  F.,  eds.  Environmental quality and  safety:  supplement v.
      2).
                                             13-51

-------
Gross,  S.  B.  (1979) Oral and  inhalation  lead exposures in human  subjects  (Kehoe balance ex-
     periments). New York, NY: Lead Industries Association.

Gross,  S.  B.  (1981) Human oral and inhalation exposures to lead: summary of Kehoe balance ex-
     periments. J. Toxicol.  Environ. Health 8: 333-377.

Hammond, P. B.; 0'Flaherty,  E. J.; Gartside, P. S. (1981) The impact of air-lead on blood-lead
     in man - a critique of the recent literature. Food Cosmet. Toxicol. 19: 631-638.

Kang, H.  K.;  Infante,  P. F. ; Carra, J. S. (1983) Determination of blood-lead elimination pat-
     terns of primary lead smelter workers. J. Toxicol. Environ. Health 11: 199-210.

Kehoe,  R.  A.   (1961a)  The metabolism of  lead  in  man in health and  disease:  the normal meta-
     bolism of lead.  (The Harben lectures,  1960).  J.  R.  Inst. Public  Health  Hyg.  24: 81-97.

Kehoe,  R.  A.  (1961b)  The metabolism of  lead in man in health  and disease: the metabolism of
     lead  under abnormal conditions.  (The Harben lectures, 1960).  J.  R.  Inst.  Public Health
     Hyg. 24:  129-143.

Kehoe,  R.  A.   (1961c)  The metabolism  of  lead in man  in health  and disease:  present  hygienic
     problems  relating  to the  absorption of  lead.  (The Harben  lectures,  1960).  J.   R. Inst.
     Public Health Hyg.  24:  177-203.

Mahaffey,  K.  R. ;  Michaelson,  I.  A.  (1980)  The  interaction  between lead  and nutrition. In:
     Needleman, H.  L.,  ed.   Low level  lead exposure:  the clinical implications  of  current
     research. New York, NY:  Raven Press;  pp. 159-200.

National  Center  for  Health  Statistics.  (1985) Births, marriages,  divorces, and  deaths for
     1984. Hyattsville, MO:  U. S. Department of Health and  Human Services;  (NCHS monthly vital
     statistics report vol.  33 no. 12).

O'Flaherty, E.  J. ;  Hammond,  P.  B.;  Lerner, S.  I.  (1982) Dependence  of apparent blood lead
     half-life  on the length  of  previous lead exposure in humans.  Fundam. Appl. Toxicol.  2:
     49-54.

Otto, D. A.; Benignus, V. A.; Muller,  K.  E.; Barton, C. N.  (1981)  Effects of age  and  body lead
     burden  on CNS function   in  young   children.  I.  Slow  cortical  potentials.  Electroen-
     cephalogr. Clin.  Neurophysiol.  52: 229-239.

Otto, D.;  Benignus, V.;  Muller, K. ;  Barton,  C.; Seiple,  K.;  Prah, J.;  Schroeder,  S. (1982)
     Effects of low to moderate lead  exposure  on slow cortical potentials in young  children:
     two year  follow-up  study. Neurobehav. Toxicol.  Teratol. 4: 733-737.

Otto, D.; Benignus,  V.; Muller, K.; Barton,  C.  (1983)  Electrophysiological  evidence of changes
     in  CNS function  at low-to-moderate blood  lead  levels  in  children.   In:  Rutter, M.;
     Russell Jones,  R.,  eds.   Lead  versus health:  sources and effects of  low level  lead ex-
     posure. New  York, NY: John Wiley & Sons; pp.  319-331.

Piomelli, S.;  Seaman, C.; Zullow, D.;  Curran, A.;  Davidow,  B.  (1982) Threshold for  lead damage
     to  heme synthesis in urban children.  Proc. Natl.  Acad. Sci. U.S.A. 79: 3335-3339.

Pocock,  S.  J.; Shaper, A. G.; Walker, M.; Wale, C.  J.; Clayton, B.; Delves, T.;  Lacey, R. F.;
     Packham,  R.  F.; Powell, P.  (1983) Effects  of  tap  water lead,  water hardness, alcohol, and
     cigarettes on blood  lead  concentrations. J. Epidemiol. Comm.  Health  37:  1-7.

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Rabinowitz,  M.  B.;  Wetherill,  G.  W.;  Kopple, J.  D.  (1973) Lead metabolism in the normal human:
     stable  isotope studies.  Science  (Washington, DC) 182:  725-727.

Rabinowitz,  M.  B.; Wetherill,  G.  W.;  Kopple, J.  D.  (1976)  Kinetic analysis of lead metabolism
     in healthy humans.  J.  Clin.  Invest.  58: 260-270.

Rabinowitz,  M.  B.; Wetherill,  G.  W.;  Kopple, J. 0.  (1977) Magnitude of lead intake from res-
     piration by normal  man.  J. Lab.  Clin.  Med.  90:  238-248.

Roels,  H.;   Buchet,  J.-P.;  Lauwerys,  R.;  Hubermont,  G.; Bruaux,  P.;  Claeys-Thoreau,  F.;
     Lafontaine, A.; Van Overschelde, J. (1976) Impact  of air pollution  by  lead  on the heme
     biosynthetic pathway in school-age children. Arch. Environ. Health 31: 310-316.

Roels, H. A.;  Buchet,  J.-P.;   Lauwerys, R.  R.; Bruaux, P.;  Claeys-Thoreau, F.; Lafontaine, A.;
     Verduyn,  G.  (1980) Exposure  to  lead  by  the oral  and the  pulmonary routes  of  children
     living  in the vicinity of a primary lead smelter. Environ. Res. 22: 81-94.

Ryu,  J.  E.; Ziegler,  E. E.;  Nelson, S. E.;  Fomon, S.  J.  (1983)  Dietary intake  of  lead and
     blood lead concentration  in early infancy.  Am.  J. Dis.  Child.  137: 886-891.

Sherlock, J. ;  Smart, G.;  Forbes, G.  I.;  Moore, M.  R.;  Patterson,  W.  J.;  Richards, W.  N.;
     Wilson, T. S. (1982) Assessment  of  lead intakes and dose-response  for a  population  in Ayr
     exposed to a  plumbsolvent water  supply. Hum. Toxicol.  1:  115-122.

Spengler,  J.  D. ;  Billick,  I.;  Ryan,  P. B. (1984)  Modeling population exposures  to  airborne
      lead.   In:  Berglund,  B.;  Lindvall, T.;  Sundell,  J., eds.  Indoor  air:  v.  4,  chemical
     characterization  and  personal   exposure;  August;  Stockholm,  Sweden. Stockholm,  Sweden:
     Swedish Council for Building  Research;  pp.  87-94.

Stark,  A.  D.;  Quah, R.  P.;  Meigs,  J. W.;  DeLouise,  E.  R.  (1982) The  relationship of environ-
     mental  lead  to  blood-lead levels in children.  Environ. Res.  27:  372-383.

U.  S.  Bureau of the  Census.   (1983)  Number  of  inhabitants: United States Summary.  Report  no.
      PC80-1-A1.   Available   from:   U.  S.   Department  of   Commerce,   Bureau  of  the  Census,
     Washington,  DC.

U.  S.  Bureau of the Census.  (1984)  1980 census of  population and housing:  Current population
      reports,  series  P-25(952):  projection of  the  population of  the U.  S. by age,  sex,  and
      race:   1983-2080.  Available from:  U.   S.  Department  of  Commerce,  Bureau of  the Census,
      Washington,  DC.

 U.  S.  Centers   for Disease  Control.   (1985) Preventing lead  poisoning  in young  children:  A
      statement by the  Centers of Disease Control, January 1985.  Atlanta, GA: U. S. Department
      of Health and Human Services; no. 99-2230.

 United  Kingdom  Central Directorate  on  Environmental Pollution.  (1982)  The Glasgow  duplicate
      diet study  (1979/1980):  a  joint survey for  the  Department  of the  Environment and the
      Ministry  of Agriculture,   Fisheries   and  Food.  London, United  Kingdom:  Her  Majesty's
      Stationery Office; pollution report no. 11.

 Walter, S.  D.; Yankel,  A.  J.; von  Lindern,  I. H.  (1980) Age-specific risk factors for  lead
      absorption in children.  Arch. Environ. Health  35:  53-58.
                                             13-53

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 Yankel,  A.  J.;  von  Lindern,  I.  H.;  Walter,  S.  D.  (1977) The Silver  Valley lead study: the
      relationship  between  childhood  blood lead  levels  and environmental  exposure.  J.  Air
      Pollut. Control  Assoc.  27:  763-767.
                                            13-54

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